Patent Application
20080126478
The present invention relates to a method and apparatus for collecting descriptive information relating to an image.
It is well known that methods are required to determine the effectiveness of medicaments. Typically, a new medicament is initially tested on animals before being tested on humans. Tests on humans often involve dividing a group of humans suffering from a condition which it is desired to treat into two sub groups. A first sub group is provided with a placebo (i.e. a substance having no therapeutic affect), and a second group is provided with the medicament, the effectiveness of which is to be tested. By comparing symptoms within the first and second sub groups, the effectiveness of the medicament as compared to the placebo can be determined.
Methods of measuring medicament effectiveness are highly dependent upon the condition which is to be treated. For some conditions an objective measure of effectiveness can easily be derived. For example, if a medicament is intended to reduce cholesterol levels, taking cholesterol readings of the patients in the first and second sub groups will determine the effectiveness of the medicament. In other cases such an objective measure cannot easily be derived. One example of such a case is an assessment of the effectiveness of a medicament for promoting wound healing and/or reducing scarring, which is at least partially subjective.
The term “wound” is exemplified by, but not limited to, injuries to the skin. Other types of wound can involve damage, injury or trauma to an internal tissue or organ such as the lung, kidney, heart, gut, tendons or liver.
The response to wounding is common throughout all adult mammals. It follows the same pattern, and leads to the same result, formation of a scar. Many different processes are at work during the healing response, and much research has been conducted into discovering what mediates these processes, and how they interact with each other to produce the final outcome.
The healing response arises as the evolutionary solution to the biological imperative to prevent the death of a wounded animal. Thus, to overcome the risk of mortality due to infection or blood loss, the body reacts rapidly to repair the damaged area, rather than attempt to regenerate the damaged tissue.
A scar may be defined as the structure produced as a result of the reparative response. Since the injured tissue is not regenerated to attain the same tissue architecture present before wounding a scar may be identified by virtue of its abnormal morphology as compared to unwounded tissue. Scars are composed of connective tissue deposited during the healing process. A scar may comprise connective tissue that has an abnormal organisation (as seen in scars of the skin) and/or connective tissue that is present in an abnormally increased amount (as seen in scars of the central nervous system). Most scars consist of both abnormally organised and excess connective tissue.
The abnormal structure of scars may be observed with reference to both their internal structure (which may be determined by means of microscopic analysis) and their external appearance (which may be assessed macroscopically).
Extracellular matrix (ECM) molecules comprise the major structural component of both unwounded and scarred skin. In unwounded skin these molecules form fibres that have a characteristic random arrangement that is commonly referred to as a “basket-weave”. In general the fibres observed within unwounded skin are of larger diameter than those seen in scars. Fibres in scars also exhibit a marked degree of alignment with each other as compared to the fibres of unwounded skin. Both the size and arrangement of ECM may contribute to scars' altered mechanical properties, most notably increased stiffness, when compared with normal, unwounded skin.
Viewed macroscopically, scars may be depressed below the surface of the surrounding tissue, or elevated above the surface of the undamaged skin. Scars may be relatively darker coloured than the unwounded tissue (hyperpigmentation) or may have a paler colour (hypopigmentation) than their surroundings. Scars may also be redder than the surrounding skin. Either hyperpigmented or hypopigmented or redder scars constitute a readily apparent cosmetic defect. It has been shown that the cosmetic appearance of a scar is one of the major factors contributing to the psychological impact of wounds upon the sufferer, and that these effects can remain long after the wound itself has healed.
Scars may also have deleterious physical effects upon the sufferer. These effects typically arise as a result of the mechanical differences between scars and unwounded skin. The abnormal structure and composition of scars mean that they are typically less flexible than normal skin. As a result scars may be responsible for impairment of normal function (such as in the case of scars covering joints which may restrict the possible range of movement) and may retard normal growth if present from an early age.
The effects outlined above may all arise as a result of the normal progression of the wound healing response. There are, however, many ways in which this response may be abnormally altered; and these are frequently associated with even more damaging results.
One way in which the healing response may be altered is through the production of abnormal excessive scarring. Hypertrophic scars represent a severe form of scarring, and hypertrophic scars have marked adverse effects on the sufferer. Hypertrophic scars are elevated above the normal surface of the skin and contain excessive collagen arranged in an abnormal pattern. As a result such scars are often associated with a marked loss of normal mechanical function. This may be exacerbated by the tendency of hypertrophic scars to undergo contraction after their formation, an activity normally ascribed to their abnormal expression of muscle-related proteins (particularly smooth-muscle actin). Children suffer from an increased likelihood of hypertrophic scar formation, particularly as a result of burn injuries.
Keloids are another common form of pathological scarring. Keloid scars are not only elevated above the surface of the skin but also extend beyond the boundaries of the original injury. Keloids contain excessive connective tissue that is organised in an abnormal fashion, normally manifested as whirls of collagenous tissue. The causes of keloid formation are open to conjecture, but it is generally recognised that some individuals have a genetic predisposition to their formation. Both hypertrophic scars and keloids are particularly common in Afro-Caribbean and Mongoloid races.
Whilst the above considerations apply primarily to the effects of wound healing in man, it will be appreciated that the wound healing response, as well as its disadvantages and potential abnormalities, is conserved between most species of animals. Thus the problems outlined above are also applicable to non-human animals, and particularly veterinary or domestic animals (e.g. horses, cattle, dogs, cats etc). By way of example, it is well known that adhesions resulting from the inappropriate healing of abdominal wounds constitute a major reason for the veterinary destruction of horses (particularly race horses). Similarly the tendons and ligaments of domestic or veterinary animals are also frequently subject to injury, and healing of these injuries may also lead to scarring associated with increased animal mortality.
From the preceding discussion, it will be appreciated that there is a need for a method of measuring the effectiveness of wound healing and scar reduction medicaments. Given that some of the disadvantageous effects of scars are psychological there is no objective chemical or biochemical test which can properly determine the effectiveness of a scar reduction therapy in overcoming such psychological effects. Indeed, an important indicator in assessing scar reduction is the subjective response to scars which have been treated with the medicament as compared to scars which have not been treated with that medicament. This problem is complicated by the fact that scar reduction therapies are normally tested on volunteers who are wounded in a clinical test and then have the medicament applied to them. Therefore, the scar which is being improved is often one created for the purposes of the clinical test.
It is known to use visual analogue scoring to measure severity of scarring. This is achieved by showing an assessor a plurality of scars and asking that they indicate on a scale extending from a low value to a high value the severity of the scar. Marks marked on the visual scale are then converted to scores to determine the relative perceived severity of scarring and by using this technique with images of scars which have or have not been subjected to the medicament a measure of medicament effectiveness can be derived.
Although visual analogue scoring does provide valuable data it will be appreciated that implementing a visual analogue scoring system is not straightforward, particularly, given that the information to be collected must be collected in a regulatory compliant fashion so as to satisfy various drug approval agents such as the Food and Drug Administration (FDA) in the United States. Similar problems occur when other metrics are used to obtain data relating to images.
Where the information is to be collected electronically, for example, using computers, any computer system must satisfy the requirements of 21 CFR Part 11, set out in Part II of the US Federal register and entitled “Electronic Records; Electronic Signatures; Final Rule, Electronic Submissions; Establishment of Public Docket; Notice”, Department of Health and Human Services, Food and Drug Administration, 20 Mar. 1997, the contents of which are herein incorporated by reference. Heretofore there has been no electronic system suitable for collection of data relating to images which satisfies the onerous requirements of 21 CFR Part 11.
It is an object of the present invention to obviate or mitigate at least some of the problems outlined above.
Embodiments of the present invention will now be described, by way of example, with reference to the accompanying drawings, in which:
According to the present invention, there is provided a method and apparatus of collecting information relating to an image. The method comprises presenting the image, receiving a plurality of data items relating to said image, each of said data items being received from one of a plurality of computers, associating said data items with an identifier identifying said image, and storing each data item together with the associated identifier in a data repository.
Thus the invention allows an image to be presented and data relating to that image to be collected from a plurality of assessors using a plurality of computers. The data is then stored in a data repository. For example, the received data items may each represent an assessor's subjective response to the presented image.
In preferred embodiments of the present invention the data repository is a database, and more preferably a structured database handled by a database management system. For example, the data repository may be a relational database implemented using the Structured Query language and managed by a conventional database management system. The database may alternatively by an object oriented database. In some embodiments the data repository is not a database managed by a database management system, but instead a file or collection of files where collected data can be stored in a predetermined manner.
The plurality of computers may transmit data to the server in response to a request. The request may be transmitted to the plurality of computers from the server. The request may be transmitted at a first time, and the plurality of data items may be received within a predetermined time period beginning at said first time. The predetermined time may be specified by said request. The request may be configured to cause the plurality of computers to display a user interface configured to receive input resulting in creation of a data item.
In some embodiments of the present invention, the image is an image of human or animal skin, and the skin may include a scar. In such circumstances the received data may provide information indicating perceived severity of scarring within the displayed image. Therefore if data is collected for a plurality of different images, each showing a different scar, and only some of these scars have been treated using a particular medicament, the invention allows information to be collected which allows the effectiveness of the medicament to be assessed. It should be noted that the collected information represents a subjective assessment of the degree of scarring, and can therefore take into account likely psychological effects of the scarring.
Each of the data items may comprise a real number within a predetermined range and the real number may represent perceived severity of said scar. The real number may be generated using a visual analogue scoring method. More specifically, assessors may be presented with a user interface comprising a scale, and input data indicating user input of a point on said scale may then be received. The input of a point on said scale to said may then be converted into a real number.
The converting described above can be carried out in any convenient way. For example, a first real number value may be defined to correspond to a first end of said scale, and a second real number value may be defined to correspond to a second end of scale. By computing a distance from said first end of said scale to said point, this distance can be converted to a real value on the basis of the distance between said first and second ends, and said first and second real number values.
The present invention also allows data to be collected which indicates a comparison between a plurality of images, and each image of the plurality of images may be an image of a scar. Here, each of the data items may indicate whether there is a perceived difference between the severity of said scars. If one of said data items indicates that there is a perceived difference between the severity of said scars, said one data item may further indicate which of said images shows least severe scarring. The plurality of images may be a pair of images.
A user interface may be displayed on a display device, and the user interface may include a plurality of user selectable buttons. Input data indicative of user selection of one of said buttons may then be received. More specifically, where the plurality of images is a pair of images, said user interface may comprise three buttons. A first button may be selectable to indicate that a first image of said pair of images shows less severe scarring, a second button may be selectable to indicate that a second image of said pair of images shows less severe scarring and a third button may be selectable to indicate that said first and second images show scarring of similar severity.
The method may further comprise providing computer program code to each of said plurality of computers, and the program code may be executable at one of said plurality of computers to generate one of said data items. In this way, different assessment data may be collected depending upon the computer program code which is provided. Thus, the invention allows the assessment data which is to be collected to be easily modified. The computer program code may include computer program code executable to provide an interface to control data collection to generate one of said data items.
If input data indicative of user selection of said first button or said second button is received, a further user interface may then be displayed. This further user interface may be configured to receive input data indicative of a degree of difference between severity of scarring shown in said first and second images of said pair of images. More specifically, the further user interface may present a pair of buttons, a first button indicating that said difference is slight, and a second button indicating that said difference is marked.
Data defining a plurality of users may be stored. These data may include a username and password for each of said plurality of users. Data indicating a number of user logons which are required to allow information collection may also be stored, and the required number of logons may be determined from user input data.
The method may further comprise, before presentation of said image, receiving a logon request, said logon request being received from one of said plurality of computers, and including a username and password, validating said received logon request using said data defining a plurality of users and generating data indicating a logon if but only if said validation is successful. Before presentation of said image, the method may comprise receiving at least as many logon requests as said required number of logons, and generating data indicating said required number of logons. A logon request may be denied if said specified number of users are logged on.
The image may be presented for not longer than a maximum image presentation time, and the maximum image presentation time may be determined by user input data. The image may be presented either for the maximum image presentation time or until a data item associated with each of said logons has been received.
If a data item associated with one of said logons has not been received when said maximum presentation time is reached, data indicating each of said logons for which data has not been received, and said image may be generated. Additionally, the image may be represented, and a data item associated with each of said indicated logons may be received.
The image may be presented using a projector which projects the image onto a screen visible by operators of the plurality of computers. Alternatively, the image may be presented by displaying the image on a display device such as a plasma screen visible by operators of the plurality of computers. Each of said plurality of data items may be received using the TCP/IP protocol or any other suitable protocol such as for example NetBEUI or IPX.
Storing each data item with its associated identifier in a database may further comprise storing with each data item a date and time at which it was received, and/or storing with each data item data indicating a user logon at the computer providing said data item. Each of said data items together with the associated identifier may be transmitted to a remote database server.
The method may comprise sequentially presenting a plurality of images, and receiving a plurality of data items relating to each of said plurality of images. The images may be presented in a random or pseudo-random order. Some of said plurality of presented images may be identical.
A report indicating user logons for which data items have not been received may be generated and this report may indicate images for which a data item has not been received.
The invention as described above can be implemented by suitably programming a computer. The invention therefore also provides a data carrier carrying computer readable instructions configured to cause a computer to carry out the method described in the preceding paragraphs.
The invention also provides a computer apparatus comprising a program memory storing processor readable instructions, and a processor configured to read and execute instructions stored in said program memory. The processor readable instructions comprise instructions controlling the processor to carry out the method described above.
The invention may be implemented in the context of a distributed system, and accordingly the invention further provides a method and apparatus for collecting information relating to an image. The method comprises presenting the image from a first computer, generating a plurality of data items relating to said image each of said data items being generated by one of a plurality of second computers connected to said first computer, transmitting each of said data items from a respective one of the plurality of second computers to the first computer, receiving each of said data items at the first computer, associating said data items with an identifier identifying said image, and storing each data item together with the associated identifier in a database.
The present invention further provides a system for collecting information relating to an image, the system comprises a first computer in communication with a plurality of second computers. The first computer is configured to present the image. Each of the second computers is configured to capture a data item relating to the image and to transmit said data item to said first computer. The first computer is configured to receive said data items, to associate an identifier identifying said image with each data item, and to output each data item together with the associated identifier to a database.
The system may further comprise a database server connected to said first computer. The first computer may be further configured to transmit said data items together with the associated identifier to the database server. Communication between said first computer and said database server may be a wired connection or a wireless connection. Similarly, communication between the first computer and the second computers may be a wired or wireless connection. For example, if a wireless connection is used, the first computer and the second computers may be connected together using a wireless local area network (WLAN)
The invention also provides a method and apparatus for collecting assessment data relating to displayed data. The method comprises providing computer program code to a plurality of second computers, said computer program code being executable at each of said second computers to control collection of said assessment data, presenting said displayed data, and receiving assessment data relating to said displayed data from each of said plurality of second computers, said assessment data being generated at each of said second computers by execution of said computer program code.
Thus, a method is provided in which the assessment data to be collected is specified by a first computer to the plurality of second computers. Thus, if different assessment data is to be collected, this can be achieved by simply providing different computer program code to the first computer and arranging that this is provided to the second computers as and when appropriate.
The displayed data may be image data. The computer program code may be executable to display a user interface configured to receive user input to generate one of said data items. The method may further comprise storing a plurality of computer programs, each computer program being defined by respective computer program code, and receiving user input indicating selection of one of said computer programs. Providing computer program code may then comprise providing computer program code defining said selected computer program.
It will be appreciated that various features of the invention described above in the context of one aspect of the invention can be applied to the other described aspects of the invention.
Referring first to
The router 7 has an interface to allow connection to the Internet 10. Via the Internet 10, the router 7 can communicate with a further remote router 11 which is connected a database server 12. Communication across the Internet 10 is carried out using a frame relay connection of a type which will be readily known to one skilled in the art. The database server 12 hosts an Oracle Clinical database, that is an Oracle database having various predefined tables which are particularly suitable for storing data related to clinical research.
It will be appreciated that the router 7 can communicate with the remote router 11 over any suitable network, which need not necessarily be the Internet 10. It will also be appreciated that in alternative embodiments of the present invention other secure communication mechanisms may be used to enable communication across the Internet 10, such as a Virtual Private Network (VPN). In some embodiments a non-secure communications channel may be used with encryption being used to ensure data security. The database server 12 need not host an Oracle Clinical database, but can instead host any suitable database, for example a ClinTrial database which is also particularly suitable for storing data relating to clinical research.
The controller PC 8 operates using either the Microsoft Windows 2000 or Microsoft Windows XP operating system. The tablet PCs 2, 3, 4 operate using versions of these operating systems particularly designed for use on tablet PCs. Each of the tablet PCs 2, 3, 4 includes a touch screen which allows data to be input using a touch pen. The tablet PCs 2, 3, 4, are additionally provided with conventional keyboards but keyboards are not used in the embodiments of the invention described herein.
The components illustrated in
An overview of the operation of the system of
At step S1a a database for storage of the data is selected. At step S2, an assessment method is selected and this selection indicates the type of assessment data that is to be collected relating to the displayed images. At step S3, the coordinator specifies a number of assessors from whom data is to be collected. This will correspond to a number of users each logging in to one of the tablet PCs 2, 3, 4. At step S4, images for display are loaded onto the hard disk 15 of the controller PC 8 from a CD ROM inserted into the CD ROM reader 16. At step S5, the controller PC 8 transmits a start message to each of the tablet PCs 2, 3, 4 via the switches 5, 6 and associated network cabling. At step S6, assessors logon using the tablet PCs 2, 3, 4 and this logon data is passed to the controller PC 8. When all necessary users have logged on, and other initialisation processing has been carried out (as described in further detail below), a first image is read from the data memory 14b and displayed to the assessors via the projector 9 (step S7).
At step S8, assessment data from each of the assessors is received at the controller PC 8 from the tablet PCs 2, 3, 4. Having received data from each of the tablet PCs 2, 3, 4, at the controller PC 8, the received data is uploaded to the database server 12 at step S9. Steps S7, S8 and S9 are repeated for each image for which data is to be collected. Embodiments of the present invention provide functionality to ensure that each assessor provides information for each image, and this functionality is described in further detail below.
An Oracle clinical connection module 28 is provided to allow data to be transferred from the controller PC 8 via the router 7 and remote router 11 to the Oracle clinical database stored on the database server 12. Finally, the controller software 22 comprises a local database 29 storing data pertinent to operation of the system as is described in further detail below.
The structure of the assessor software 23 is now described. The assessor software comprises a first group of modules 30 which provide general assessor functionality, a second group of modules 31 which provide functionality appropriate to the collection of a first type of assessment data, and third group of modules 32 which allow collection of a different type of assessment data. The first group of modules 30 comprises a security module 33 providing security functionality such as that described above with reference to the security module 27, but in the context of the tablet PCs 2, 3, 4. A TCP/IP module 34 provides functionality to allow the tablet PCs 2, 3, 4 to communicate with other components connected to the network illustrated in
The second group of modules 31 comprises a TCP/IP module 36 containing functionality specific to collection of assessment data using the second group of modules 31, and an Assessment Type I module providing functionality specific to collection of a first type of assessment data. The third group of modules 32 again comprises a TCP/IP module 38, and an Assessment Type II module 39 providing functionality specific to collection of a second type of assessment data.
Each of the software components illustrated in
Referring to
In order to control user access of the system, a SECURITY_GROUPS table 41 defines a plurality security groups each having an identifier stored in a Security_Group_ID field and an associated name stored in a Name field. Each of these security groups has associated with them different access permissions.
A USERS table 42 is used to store details of users who are authorised to use the system. The USERS table comprises a Username field storing a textual username for each user, a Password field storing a password, an Encrypted field indicating whether the password is stored in encrypted form, a date and time value indicating the password's expiry date in a Password_Expiry_Date field, a Full_Name field storing a full name for the user and a Security_Group_ID field identifying one of the records in the SECURITY_GROUPS table 41. The USERS table 42 further contains a Login_Attempts field storing the number of login attempts that a particular user has made, a Locked field indicating whether a user is locked out of the system, and a Disabled field. The Disabled field allows particular user records to be disabled by a administrator if that particular user is not to logon for any reason.
A LOGIN_SESSION table 43 contains data relating to a particular users logon session. A Session_GUID field stores a unique identifier for that session. A Username field identifies a particular user's record in the USERS table 42. A Machine_ID field and an IP_Address field provide details identifying one of the tablet PCs 2, 3, 4 to which the user is logging in. A Login_Timestamp field stores data indicating when a user logged on. A Logged_Out field indicated whether or not a user has yet logged out and a Logged_Out_Timestamp field indicates a date and time at which the user logged out. A Logged_Out_Reason field allows a reason for the log out to be specified. A login session as represented by a record of the LOGIN_SESSION table 43 represents a particular user's logon. In contrast, an assessment session as indicated by record in the ASSESSMENT_SESSIONS table 44 stores details relating to a complete assessment session comprising a plurality of records in the LOGIN_SESSION table 43. An Assessment_Session_GUID field of the LOGIN_SESSION table 43 uniquely identifies a particular assessment session of the table 44 to which the login pertains.
The ASSESSMENT_SESSIONS table 44 comprises a unique identifier stored in an Assessment_Session_GUID field. A Start_Timestamp field stores a data and time at which a session begins, and an End_Timestamp field stores a date and time at which a session ends. A Number_of_Images field indicates a number of images which are to be displayed and assessed during the assessment session. The Session_GUID field identifies one or more records of the LOGIN_SESSION table 43 indicating the user logins which are responsible for providing assessment data for a particular assessment session. A Number_of_Assessors field indicates the number of assessors contributing data to that particular assessment session. A Scoring_Time field indicates a length of time for which images are to be displayed to the assessor. An OC_Study field identifies a group of records (referred to as a study) in the Oracle Clinical database stored on the database server 12. This data is used to ensure that the controller PC 8 passes received assessment data to the correct part of the Oracle clinical database stored on the database server 12. A Training_Session field indicates whether or not the session is designated as a training session, the significance of which is described in further detail below.
It has been described above that the data to be collected about an image can be of one of a plurality of different types. The type of data to be collected is identified by an assessment module, and a Module_GUID field identifies a record in the ASSESSMENT_MODULES table 45 which provides details of the data to be collected. The ASSESSMENT_MODULES table 45 comprises a Module_GUID field providing a unique identifier for the module, a Name field providing a name for that module and Local_Path field indicating where code relating to that module can be found on the controller PC 8. By storing computer program code needed to capture assessment data on the controller PC 8, the appropriate assessment module (corresponding to one of the modules 31, 32 of
A NON_ASSESSED_IMAGES table 46 is used to allow details of missing data to be captured. It has been explained above that embodiments of the invention can allow mechanisms to be put in place to ensure that data is collected from each assessor for each displayed image. And the NON_ASSESSED_IMAGES table is used to provide this functionality. This table comprises a Non_Assessed_Image_GUID field storing a unique identifier, a Session_GUID field identifying a login session which failed to provide assessment data, an Assessment_Session_GUID field which identifies a record in the ASSESSMENT SESSIONS table 44 representing an assessment session in which the image was displayed, and Image_ID an Image_Type fields which provide details of the image for which data is missing. Use of this table is described in further detail below.
The tables illustrated in
The tables illustrated in
The AUDIT_ASSESSMENT_SESSIONS table 48 is populated by the triggers firing against the ASSESSMENT SESSIONS table. These triggers record insert, update and delete operations relating to records of the ASSESSMENT_SESSIONS table 44. From the description set out above, it will be appreciated that records are stored to the ASSESSMENT_SESSIONS table 44 during the creation, running and completion of assessment sessions using the software.
The AUDIT_USERS table 49 is populated by triggers firing against the USERS table. These triggers record insert, update and delete operations relating to records of the USERS table. Records are stored in the USERS table 42 during the creation, modification and de-activation of users. The triggers of the AUDIT_USERS table 49 also record events such as password changes.
The AUDIT_NON_ASSESSED_IMAGES table 50 is populated by triggers firing against the NON_ASSESSED_IMAGES table 46. These triggers record insert, update and delete operations relating to the NON_ASSESSED_IMAGES table 46, Records are stored in the NON_ASSESSED_IMAGES table 56 when a user/users do not record an assessment of an image displayed and such records are manipulated by the software as it progresses through the scoring session, as described in further detail below.
The AUDIT_SECURITY_GROUPS table 52 is populated by triggers firing against the SECURITY_GROUPS table 41. These triggers record insert, update and delete operations relating to the SECURITY_GROUP table 41. Records are not inserted, updated or deleted in the SECURITY_GROUPS table 41 by the software but creation, modification and deletions of records of the SECURITY_GROUPS table 41 are performed directly to the database a audited in the AUDIT_SECURITY_GROUPS table 52.
It should be noted that for each entry recorded into one of the audit tables of
Operation of the system to allow display of images and collection of assessment data is now described in further detail. Referring first to
Referring now to
If, on being displayed with the dialog at step S18, a user chooses to continue with the currently active assessment session, the controller PC produces a random list of unscored images from the currently active assessment session. This is created by determining which images have not yet been displayed to a user, and can be deduced by comparing images stored on the controller PC 8 in appropriate folders (described below) with images for which data is stored in the Oracle Clinical database, or for which a record exists in NON_ASSESSED_IMAGES table 46 (step S21). Processing then passes to step S22, which diverts processing to step S35 of
Referring now to
It should be noted that in the described embodiment of the present invention, it is required that the first and second CD ROMs inserted into the CD ROM reader 16 are different CD ROMs. This is facilitated by storing the volume label of the first CD ROM when data is read from that CD ROM, and comparing this stored volume label with that of the second CD ROM. This comparison is carried out at step S29, and if it is determined that the volume labels do match (indicating that the same CD ROM has been placed in the CD ROM reader twice) an appropriate error message is displayed to the user at step S30, and processing returns to step S28 where the user can insert a further CD ROM into the CD ROM reader 16 and select the second image load button 57 to cause images to be loaded in the “batch 2” folder of the controller PC 8. It should be noted that no images are actually copied from the CD ROM to the “batch 2” folder until the check of step S29 indicates that the first and second CD ROMS are different. Images are loaded from the CD ROM into the “batch 2” folder at step S31.
Having loaded appropriate images into the “batch 1” and “batch 2” folders of the controller PC 8 processing then passes to step S32 where a randomly ordered list of images stored in both the “batch 1” and the “batch 2” folders of the controller PC 8 is created. It should be noted that this randomly ordered list may contain some images more than once.
The division of images into two distinct folders allows two distinct subpopulations of images to be created. When data relating to an image is captured, it is stored together with data identifying the image to which it relates. The identifier identifying each image can be generated so as to indicate whether the image is taken from the “batch 1” folder or the “batch 2” folder, therefore allowing captured data relating to the two subpopulations of data to be distinguished within the stored data. For example, images stored in the “batch 1” folder may be those for which scoring data is to be collected and stored, while images stored in the “batch 2” folder may be those which are to be used for consistency checking. For example, the “batch 2” folder may contain a number of images which are to be repeated so as to ensure scorer consistency. The images stored in the “batch 2” folder may also be common to a number of assessment sessions so as to allow inter-session consistency to be monitored.
At step S33, the user uses a slider bar 58 to input into the dialog 53 a number of assessors who are to contribute assessment data for this assessment session. At step S34, a user uses a slider bar 59 to input a time value indicating a number of seconds with which assessors will be provided to provide assessment data (as described below). The processing described above with reference to steps S23 to S34 provides all data required to configure an assessment session. It should be noted that the dialog 53 is configured to ensure that the steps described above are carried out in the order in which they are described by only enabling particular elements of the dialog 53 after certain elements have been used to provide particular information. For example it can be seen that in
Having configured an assessment session in the manner described above, processing then passes to step S35 where a user uses a button 60 to trigger acceptance of client connections. Each client connection will be a connection from an assessor using one of the tablet PCs 2, 3, 4 to provide assessment data. Each client connection will be associated with a record in the LOGIN_SESSION table 43 of the local database. The controller PC then waits until the requisite number of connections has been received. At step S36 a check is carried out to determine whether the coordinator has chosen to cancel the assessment session. Assuming that the session has not been cancelled processing passes to step S37 where a check is carried out to determine whether the specified number of connections have been made. Assuming that the specified number of connections has not been made steps S36 and S37 are repeated until such time as either the required number of connections has been made or the user chooses to cancel the session. If the user chooses to cancel the session at step S36, images are deleted from both the “batch 1” and “batch 2” folders on the hard disk 15 of the controller PC 8 at step S38, and records of the LOGIN_SESSION table 43 relating to logins for the particular assessment session are appropriately updated at step S39. Having done this, at step S40 processing returns to
Assuming that the session is not cancelled at step S36 the loop of step S36 and S37 exits when the specified number of connections has been received. When the specified number of connections is received processing passes to step S41 at which a user is presented with further dialog which is used to commence an assessment session. This dialog can also be used to choose to cancel the session by returning to the coordinator home page by selecting an appropriate button. Use of this button is detected at step S42, and if the button is selected processing passes to step S38 where the processing described above is carried out. Assuming that a user does not choose to return to the home page at step S42 a user can choose to designate that the session is a “training session”. That is a session which is to be used to train assessors and for which data is not to be written to the Oracle clinical database. This is done at S43 by entering a “tick” in an appropriate tick box of the further dialog. If a tick is placed in the tick box, processing passes to step S44 where the session is designated as a training session, the significance of which is described in further detail below. Either after designation of a session as a training session at step S44, or after processing of step 43 where the session is not a training session processing then passes to step 46 of
Referring now to
Referring now to
If the check of step of S32a determines that the combination of CDs now used has been used previously, processing passes to step S32d where a prompt is presented to the user. This prompt requires the user to either select a new randomisation or an existing randomisation, and the user input is processed at step S32e. It will be appreciated that there are benefits in allowing a user to select as between a previous randomisation and a new randomisation. Particularly, if an assessment session is to be repeated and it is desired to perform the repeated session under identical conditions to the initial session, the same randomisation would preferably be used. However if a different session is to be run a new randomisation would in that case be preferred. In the case that the input received at step S32e indicates that a new randomisation is to be generated, processing passes from step S32e to step S32b where a randomisation is generated and processing there proceeds as discussed above. If however the input received at step S32e indicates that an existing randomisation should be used, processing passes to step S32f. At step S32f, a check is carried out to determine how many randomisations are stored in the database for the combination of CDs now being used. It will be appreciated that this check will involve querying the database using CD IDs to identify data stored at step S32c of previous assessment sessions. If it is determined that there is more than one randomisation associated with this particular combination of CDs, processing passes from step S32f to step S32g where a user is prompted to select one of the previously used randomisations. This prompt preferably provides to the user a list of previously used randomisations on the basis of the date and time at which those randomisations were used. From step S32g, processing continues at step S32h where a selection of one of the displayed randomisations is received. The selected randomisation is then read at step S32i from where processing continues at step S33. If the check of step S32f determines that there is only one randomisation associated with a particular combination of CDs it can be seen that processing passes directly from step S32f to step S32i.
It will be appreciated that variant of the process for setting up an assessment session described with reference to
In embodiments of the invention in which an assessment session is set up using the process illustrated in
The processing described above with reference to
Referring first to
At step S52 a first image from the previously created randomised list (step S32,
The loop described above will exit either when assessment data is received from all assessors (step S55) or when the timeout limit is reached (step S56). If the timeout limit is reached, this is an indication that at least one of the assessors has failed to provide assessment data. Accordingly, a new record is created in the NON_ASSESSED_IMAGES table 46 of the local database stored on the controller PC 8. The Non_Assessed_Image_GUID field provides a unique identifier for the missing assessment data. The record also comprises a Session_GUID field which indicates the login session responsible for the missing data, and an Assessment_Session_GUID field identifying the current assessment session together with details of the image for which data has not been provided. When the record has been created in the NON_ASSESSED_IMAGES table 46, processing passes to step S61. It should be noted that if the loop of steps S55 to S59 exit when all responses have been received, it can be deduced that there is no missing data and accordingly processing passes directly from step S55 to step S61.
At S61 the projector 9 displays no image such that the screen is “blanked” to provide a delay between images. At step S61a a check is carried out to determine whether or not the session is marked as a training session. If the assessment session is not marked as a Training Session, data is copied from the TEMP_DATA table 40 to the Oracle Clinical database stored on the database server 12 at step S62. Having done this, records of the TEMP_DATA table can be deleted at step S63, and processing continues at step S64. If the check of step S61a determines that the current assessment session is a training session, processing passes directly to step S64. At step S64 a check is carried out to determine whether the present image is the last image to be displayed. Assuming that the image which has been displayed is not the last image, processing passes to step S64a where the next image for display is selected and processing then passes to step S53 and continues as described above. When all images have been displayed (that is if the condition of step S64 is satisfied), a check is carried out at step S65 to determine whether or not there are any unscored images (that is whether or not there are any records in the NON_ASSESSED_IMAGES table which relate to the present session.) If unscored images exist, processing passes to step S71 of
If no unscored images are located at step S65, processing passes to step S67 where a message indicating successful completion of the assessment session is displayed to the user. The assessment session record in the ASSESSMENT_SESSIONS table 44 is marked as completed at step S68, and images are deleted from the “batch 1” and the “batch 2” folders of the controller PC 8 at step S69. At step S70 processing returns to step S10 of
It was described above that if assessment data for some images has not been collected from all assessors, processing is carried out to present these images to the assessors again, so as to obtain appropriate assessment data. This processing is now described with reference to
The loop of steps S79 to S82 continues until either data is received from each appropriate assessor from whom data is required (step S79) or the timeout limit is reached (step S80). If the loop exits through the timeout of step S80, it can be deduced that at least some of the appropriate assessors have failed to provide assessment data. Details of such missing data are recorded in the NON_ASSESSED_IMAGES table at step S83, and processing then passes to step S84. It should be noted that if the loop of steps S79 to S82 exits at step S79, it can be deduced that there is no missing data, and processing therefore passes directly to step S84, where a wait command is executed to cause a delay.
At step S85, a check is carried out to determine whether further images are to be displayed. If further images are to be displayed, a next image for display is selected at step S86, and processing then continues at step S77 as described above. If however the previously displayed image is the last image to be displayed, at step S87 a check is carried out to determine whether there is still any missing data, by querying the NON_ASSESSED_IMAGES table 46. If there is no missing data, processing passes to step S88, and then to step S67 of
It should be noted that for each image for which assessment data is missing, a different set of assessors may be required to provide assessment data. This can be deduced from the NON_ASSESSED_IMAGES table 46, by discovering which users login sessions are referred to in the Session_GUID field of records having a particular Image_ID. Therefore, the check of step S79 may well differ for different images.
It should be noted that at any time during the processing described above the coordinator may choose to cancel the assessment session. This is shown in
The preceding description has been concerned with use of the controller PC 8 to set up an assessment session and collect assessment data. It has been briefly mentioned that different types of assessment data can be collected. The way in which this data is collected is now described, with reference to the graphical user interface provided to assessors using the tablet PCs 2, 3, 4, and with reference to the data which is input via that interface.
In the described embodiments two assessment schemes are used, and these are now described. From the homepage 70 at step S92, if the assessment module downloaded at step S91a relates to type 1 assessment data processing passes to step S95, and then to step S99 of
Referring to
If the assessment session has not ended, processing passes from step S100 to step S105, where a loop is established until an initiation command is received from the controller PC 8 indicating that an image has been displayed using the projector 9. When an initiation command is received, processing passes to step S106 where a data input screen 80 as illustrated in
Data is input using the scale 81 by a user using a touchpen to locate a position on the scale 81 displayed on the display screen of one of the tablet PCs 2, 3, 4. Input is awaited at step S107, and at step S108 a check is made to determine whether a timeout limit has been reached, the time out limit having been communicated to the tablet PCs 2, 3, 4 by controller PC 8. Assuming that the timeout limit is not reached, processing returns to step S106, and steps S106, S107 and S108 are repeated until either input is received, or the timeout condition is satisfied.
When input is received, the position marked on the scale 81 is converted into a real number score (step S109). The interface is configured to measure input position on the scale 81 to an accuracy of 0.05 cm. The score is then transmitted to the controller PC 8 at step S110. At steps S111 and S112 the assessor interface waits until either a timeout condition is satisfied for receipt of data from all assessors, or all other assessors have provided assessment data. Processing then passes to step S113 where the data entry screen is removed from the display of the tablet PCs 2, 3, 4. It should be noted that if at step S108 the timeout condition is satisfied and input is not received, processing passes directly from step S108 to step S113. After removal of the data entry screen (step S113), a wait command is executed at step S114 and processing then returns to step S100.
The preceding description has been concerned with the display of a single image to a user, and collection of visual analogue data relating to that image. An alternative method for collecting assessment data is described with reference to
Referring back to
Referring to
It should be noted that in this assessment mode, a pair of images is displayed to assessors for assessment using the projector 9. A first image is referred to as an anterior image, and a second image is referred to as a posterior image. The data to be collected indicates whether the scarring indicated by each image of the pair of displayed images is considered to approximately the same, whether the anterior image is better, or the posterior image is better. This information is captured using three buttons presented using the data input screen 85. A first button 86 is labelled “Image ‘A’ Better”, a second button 87 is labelled “Image ‘B’ Better” and a third button 88 “Both the same”.
At step S124 a check is made to determine whether one of the buttons 86, 87, 88 has been selected. If input has not yet been received, processing passes to step S125 where a check is made to determine whether the allocated time for providing information has expired. If time has not expired, processing returns to step S123 and steps S123 and S124 are repeated until either data is received, or time expires. If time expires, the loop exits at step S125 and processing passes to step S133, which is described below. However, if the loop exits at step S124 when input is received, at step S126 the received input data is processed to determine which of the three buttons was selected by the assessor. If the button 88 has been selected indicating that the scarring between the pair of images was substantially the same, processing then passes to step S127 where this data is transmitted to the controller PC 8.
However, if the button 86 indicating that the scarring of image A is better is selected, or the button 87 indicating that the scarring of image B is better is selected, processing passes from step S126 to step S128 where a further data input screen 90 (
Referring back to
From step S127, processing passes to step S131 where a wait message is displayed to the assessor until such time as data has been received from each of the assessors, or such time that a timeout condition is satisfied. This is achieved by the loop of steps S131 and S132. When the wait message is no longer to be displayed, processing passes to step S133, where the data entry screen is removed from the display, a wait command is executed at step S134, and processing then returns to Step S117 where it continues as described above.
The description set out above has set out two different types of assessment data which can be captured using the described embodiments of the present invention. It has also been described that data received by the controller PC 8 is initially stored in the TEMP_DATA table 40 illustrated in
In embodiments of the invention in which particular randomisations of images may be reused, as illustrated in and described with reference to
It has been mentioned above that the database stored on the controller PC 8 includes a USERS table, a LOGIN_SESSION table and a SECURITY_GROUPS table. These tables are all provided to control user access to the system using the security module 27 of the controller software 22 and the security module 33 of the assessor software 23 (
Referring first to
Assuming that the tablet PC is able to connect to the controller PC 8 at step S140, a check is made at step S143 to determine whether or not the number of assessors specified for the assessment session have connected to the controller PC. If the required number of assessors have connected, no further connections can be allowed, and accordingly a suitable error message is displayed at step S144 and processing again ends at step S142. Assuming that all assessors have not yet connected, processing passes from step S143 to step S139 where an appropriate login dialog is displayed. On being presented with the login dialog the user inputs a user name and password at step S145, and, if the details were input to one of the tablet PCs 2, 3, 4, the input details are transmitted to the controller PC 8. At step S146 a check is made to determine whether a valid user id has been entered. This involves checking that the input user id matches the Username field of a record of the USERS table 42 (
Assuming that a valid username is input, processing passes from step S146 to step S149. Checks are then made to ensure that the type of hardware which is being used for the logon (i.e. controller PC or tablet PC) matches the security group to which the user has been allocated. For example, a coordinator or administrator can only logon using the controller PC 8, while an assessor can only log on using a tablet PC 2, 3, 4. A user's security group is determined by locating the user's record in the USERS table 42 and identifying the user's security group from the Security_Group_ID field of their record. At step S149, if the hardware being used is a tablet PC, a check is made to determine whether the user's security group is administrator or coordinator. If this is the case, the log in can not be permitted, and an appropriate error message is displayed at step S150 before the system closes at step S151. However, if the hardware is the controller PC 8, or if the user's security group is assessor, then processing passes from step S149 to step S152 where a check is made to determine whether an assessor is attempting to login using the controller PC 8. If this is the case, again the login cannot be allowed, and an appropriate error message is displayed at step S153 before the system closes at step S151. If step S152 determines that an assessor is not attempting to logon using the controller PC 8, processing passes from step S152 to step S154, and it is known that the hardware being used in appropriate to the user's security group.
At step S154 a check is made to determine whether the password associated with the input username is held in the USERS table 42 in encrypted form, by checking the Encrypted field of the user's record. If the password is held in the database in encrypted form, the input password is encrypted at step S155 before being checked against that stored in the database at step S156. If the Encrypted field of the user's record indicates that the password is not stored in encrypted form, processing passes directly from step S154 to step S156. If the input password does not match that stored in the USERS table 42, processing passes from step S156 to step S157 where the number of incorrect passwords is incremented by incrementing the LoginAttempts field of the user's record in the USERS table 42 and at step (S157a) a record is stored to the ACCESS_FAILURES table indicating this failure. In the described embodiment of the invention, a user may only input an incorrect password three times before their account is disabled. At step S158, a check is made to determine whether an incorrect password has been entered three times. If this is the case the user's account is disabled at step S159 (by setting the Disabled field of the user's record in the USERS table 42), and an error message is displayed at step S160. If an incorrect password has not been entered on three occasions processing passes from step S158 to step S145 where the user is again prompted to enter their username and password.
If the input password is found to be correct at step S156, the number of incorrect passwords entered stored in the LoginAttempts field of the USERS table is reset to zero. At step S161, the status of the user's account is checked by first checking the Disabled field of the user's record in the USERS table 42. If the user's record is disabled, the user is not permitted to use the system. Accordingly an audit record is created to store details of the login attempt at step S162 and a suitable error message is displayed at step S163.
If step S161 determines that the user is already logged in (which is the case if there is a record in the LOGIN_SESSION table 43 which refers to the user's record in the USERS table 42) the user is prompted to enter their username and password again at step S164 to confirm that they wish to terminate their previous login session and login again. If the details are correctly re-entered at step S164, the user is logged out of their previous login session at step S165, and processing passes to step S166. It should be noted that login details input at step S164 are processed in a similar way to that described with reference to relevant parts of
If an assessment session is being re-started, only assessors who contributed to the original assessment session are allowed to log on to contribute assessment data. Therefore, at step S166 a check is made to determine whether or not the user is allowed to join the current assessment. If the user is not allowed to join the assessment session, an appropriate message is displayed at step S167, and processing then ends at step S168.
Assuming that the user is allowed to join the assessment session (or the user is an administrator or coordinator), processing passes from step S166 to step S169 where a check is made to determine whether the user's account has expired, by checking the Password_Expiry_Date field of the user's record in the USERS table 42. If the user's account has expired, an appropriate message is displayed at step S170. The user is then prompted to change their password at step S171, as described below with reference to
If the user has logged in as an assessor (step S173), an assessment module (appropriate to the type of assessment data which is to be collected) is provided at step S174. Processing then passes to step S175 where the user's security group is determined, and an appropriate homepage is then provided at step S176. The provided assessment module will execute to allow one of the tablet PCs 2, 3, 4 to capture the required assessment data. The downloaded assessment module will correspond to one of the modules 31, 32 illustrated in
It has been described above, that both the coordinator homepage (
Referring to
In normal operation, the user inputs their current password into the Current Password textbox 95 and their desired new password into both the New Password textbox 96 and the Confirm New Password textbox 97. The submit button 99 is then pressed. Processing then passes to step S180 where a check is made to determine whether or not the user's password is stored in the USERS table 42 of the database in encrypted form. This is indicated by the value of the Encrypted field of the user's record in the USERS table 42. If the password is stored in encrypted form, the password entered in the Current Password textbox 95 is encrypted at step S181, and processing then passes to step S182, where the entered current password is compared with that stored in the database. If the password is not held in the database in encrypted form, processing passes directly from step S180 to step S182.
At step S182, if the entered current password does not match that stored in the Password field of the appropriate record of the USERS table 42 an audit record of the failed password change attempt is made at step S183 to the ACCESS_FAILURES table 47.
Processing that passes to step S184, where the number of failed login attempts associated with the user is incremented in the USERS table 42. If three failed logins have occurred, (step S185) the user's account is disabled by appropriately setting the Disabled field (step S186) and error message is displayed at step S187 and the system closes at step S188. If the number of failed logins is not equal to three at step S185, processing passes to step S189 where an appropriate error message is displayed. Processing then returns to step S179 where the change password dialog is again displayed to the user.
If, at step S182, the input current password matches that stored in the USERS table 42 of the database, processing passes to step S190, where a check is made to ensure that the new password entered in the New Password textbox 96 matches that entered in the Confirm New Password textbox 97. If the entered passwords do not match, an error message is displayed at step S191, and the user is again presented with the Change Password dialog of
At step S196, the new password is encrypted. At step S197, the encrypted password is stored in the Password field of the user's record in the USERS table 42. The Encrypted field is set to indicate that the password has been encrypted. Additionally, the Password_Expiry_Date is set to the current date, plus sixty days. Step S198 to S202 then ensure that the user is returned to the correct homepage. Step S198 checks if the user is logged in as an assessor, and if this is the case, the assessor homepage is displayed at step S199. Otherwise, processing passes to step S200 where a check is made to determine if the user is logged in as an administrator, in which case the administrator homepage is displayed at step S201. Otherwise, the coordinator homepage is displayed at step S202.
It has been mentioned above that the various homepages provided by the described embodiment of the invention provide a logout button to allow a user to logout.
Embodiments of the present invention ensure that when a user provides login session information to the controller PC 8, this information is valid. This is illustrated in
The described embodiment of the present invention provides an administrator security group, and a user logging in as an administrator is provided with various management functionality over the system, as is now described.
Three options relate to management of users. A create user option provided at step S217, a modify user option provided at step S218, and a delete user option provided at step S219. Three options relate to the management of assessment types. At S220 a new assessment type can be created, at step S221 an existing assessment type can be modified, and at S222 an existing assessment type can be deleted. The administrator home page additionally provides an option at step S223 to modify communications information. At step S224 an administrator can choose to log out of the system, and at step S225 an administrator can choose to modify their own password. The log out and change of password procedures are those which have been described above.
Referring now to
When appropriate data has been input into the drop down list 101, and the text boxes 102, 103 the submit button 105 is pressed, and the input is received by the controller PC at step S228. At step 229 a check is made to determine whether or not the username input into the Username text box 102 already exists in the USERS table 42 of the local database 29. If the specified username does exist an error message is displayed at S230 and the create new user dialog is again displayed at S227. Assuming that a username not currently present in the USERS table 42 of the local database 29 is input into the user name textbox 102, processing passes to S231 where a new record is created in the USERS table 42 of the local database 29 containing the specified user name, user's full name, and security group for the new user. At S232 a random password for the new user is generated and this generated random password is displayed at step S233. The administrator can then make a note of the randomly generated password and pass this on to the new user, as it will be required for the new user's log on. Processing then passes to step S234 where the generated random password is stored in the Password field of the created record in the USER'S table 42 of the local database 29. Additionally, the expiry date of the randomly generated password (stored in the Password_Expiry_Date field of the USERS table 42) is set to the current date and time to ensure that the user changes their password when they first logon. The new user has then been created, and the administrator home page is again displayed to the user as indicated at step S236 which returns the processing to step S216 of
If, from the home page schematically depicted by step S216, the user selects to modify a user at Step S218, the processing illustrated in
Having selected a user to deactivate at step S249, and pressed the submit button 122, the appropriate record of the USERS table 42 of the local database 29 is updated, and more specifically the Disabled field is updated to show that the account has been deactivated at step S250. Having made the appropriate update, the administrator is returned to the home page depicted at step S216 of
Referring back to
Referring first to
Referring now to
Referring back to
In the preceding description, it has been explained that the tablet PC's 2, 3, 4 communicate with the controller PC8 using the TCP/IP protocol via the TCP IP modules 34, 36 and 38 of the assessor software 23, and the TCP module 24 of the controller software 22 (
Table 1 below shows how various commands which need to be communicated between parts of the software illustrated in
It has been described above that data is passed from the local database 29 (
Data is transferred from the TEMP_DATA table 40 of the local database 29 at step S62 of
An ASSR field of the table 150 is used to identifier an assessor who contributed the assessment data represented by a particular record. An ATYPE field of the table 150 is used to identify the type of assessment data represented by a particular record of the table (e.g. Type I or Type II assessment as described above). This data is taken from the Assessment_Type field of the TEMP_DATA table 40. An IMGID field is used to identify the image and this data is taken from the Image_Number field of the TEMP_DATA table 40. An IMGTYP field is used to identify whether the image was taken from the “batch 1” folder or “batch 2” folder of the controller PC 8. Again, by ensuring that each entry of the Image_Number field of the TEMP_DATA table 40 can be interpreted to derive a folder name, data for the IMGTYP field can be generated.
VALUE1, VALUE2, and DIFF fields together represent assessment data. The VALUE1 field corresponds to the Value—1 field of the TEMP_DATA table 40. That is, where visual analogue scoring data is stored, this field stores a real number indicating that score. Where comparative scoring data is stored, this field stores a value of ‘0’ to indicate that images show scarring of equal severity, a value of ‘1’ to indicate that a first image shows less severe scarring than a second image, and a value of ‘2’ to indicate that the second image shows less severe scarring that the first image. Similarly the DIFF field corresponds to the Difference field of the TEMP_DATA table 40. This field is therefore used only for comparative scoring. A value of ‘0’ indicates that there is no difference in severity of scarring, a value of ‘1’ indicates a slight difference and a value of ‘2’ indicates an obvious difference. The VALUE2 field is not used for collection of assessment data as described above. However, the inclusion of this field allows different types of assessment data to be collected in which a greater quantity of data needs to be stored in the table 150.
It should be noted that the PT field of the table 150 references a further table of the Oracle Clinical database which contains details of patients. Thus, in order for data for a particular patient to be stored in the table 150 a record identifying that patient must be present in the further table of the database.
It will be appreciated that data stored in the table 150 can be queried and used to generate reports. A generic Oracle Open Database Connectivity (ODBC) driver allows data to be read from the table 150.
It was described above that heretofore there was no system which allowed data relating to images to be collected which complied with the requirements of 21 CFR Part 11 (referenced above). The system described above does satisfy these requirements, and the manner in which the system satisfies the various requirements is now described.
The way in which data is stored is strictly specified by 21 CFR Part 11. It is required that any storage system allows accurate and complete copies of records to be created in human readable and electronic form, such that records can be inspected by the Food and Drug Administration (FDA). Given that collected data is passed to an Oracle Clinical database which provides such functionality, this requirement is met. Similarly, requirements relating to protection of records, provision of an audit trail and storage of previous versions of records are all provided by the Oracle Clinical database. Additionally, 21 CFR Part 11 requires that a timestamped audit trail of collected data can be generated. By storing data indicative of times at which data is collected (as set out above), and forwarding this data to the Oracle Clinical Database, this requirement is satisfied.
21 CFR Part 11 further requires that access to the system is controlled, and as described above the described system uses user names and passwords to ensure that only authorised users are allowed to access the system. Similarly, there is a requirement that passwords must be reset at predetermined time intervals, and this has been described above. Features such as locking of user accounts after three unsuccessful login attempts and storing data representing these failed logins also provide required security. Additionally various features have been described which ensure that only authorised terminals are able to provide assessment data as is requirement by 21 CFR Part 11.
21 CFR Part 11 also requires that data collection is carried out in a well defined manner. By specifying and enforcing a sequence of actions as described above this requirement is satisfied. Therefore, the described embodiment of the present invention allows data to be collected in a manner conforming to the requirements of 21 CFR Part 11.
Preferred embodiments of the present invention have been described above. However, it will be readily apparent to one skilled in the art that various modifications can be made to the described embodiments without departing from the spirit and scope of the present invention as defined by the appended claims. For example, it will be readily apparent that although only three tablet PC's 2, 3, 4 are illustrated in
| Number | Date | Country | Kind |
|---|---|---|---|
| 0427642.4 | Dec 2004 | GB | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/GB05/04787 | 12/14/2005 | WO | 00 | 1/7/2008 |
| Number | Date | Country | |
|---|---|---|---|
| 60637266 | Dec 2004 | US |
