INFORCOM - PRODUCTS - ES Scoring

Contract Research or Clinical Research Organisations carry out drug trials on voluteers. Inforcom Technologies have developed a CRO trial management application - 'Clinical Trial Volunteer Management' application (CTVM).

The current version is the systematic CRO test data storage and management. The segments covered are volunteer data management, volunteer screening management, actual drug test data management, ADR and reporting services.

The planned expansion to this application is the scheduling feature. This algorithm based approach will have many configurations for its auto operations. This will help selection of volunteers in accordance with pre-specified criteria, screening scheduling and project scheduling etc.

The first step toward drug testing is to generate a volunteer database with detailed information. The interface (form) offered is a friendly approach to enter all the basic information. (figure - 1)

The allocation of auto volunteer no. makes the indexing sound. The basic information fields are: volunteer name (first, last, middle, auto initials), Age (birth date and auto age calculation), contact information (current and permenant address, tel, fax, email etc.), physical details (height, weight, BMI ratio), medical details (blood group, ref. doctor) etc.

Facility is also provided to store and view the image of the volunteer. An image optimisation tool optimises the image size and quality.

The second step in the process is to create a project profile and input all the features of the project. This becomes the master file for further project processes and future references. (figure - 2)

Project details cover project name, project code, drug code, registration no., volunteer age limits, project dates etc.

The necesary screenings are to be selected from the options offered. A user friendly tool is offered here to include a screening or to remove it.

Data entry verification is also present to avoid data entry errors.

Drug test Project configuration

A Reson Must be given for any Change
in a Existing Record
(An ISO Requirement)

Basic Volunteer Screenings Results

Detailed Volunteer Screenings Result Entry

Volunteer Participation Status Record

Adverse Drug Reaction Reporting



		Flash Demo: The Volunteer Data Management The Screening Activity The Dosing Activity
	Contract Research or Clinical Research Organisations carry out drug trials on voluteers. Inforcom Technologies have developed a CRO trial management application - 'Clinical Trial Volunteer Management' application (CTVM). The current version is the systematic CRO test data storage and management. The segments covered are volunteer data management, volunteer screening management, actual drug test data management, ADR and reporting services. The planned expansion to this application is the scheduling feature. This algorithm based approach will have many configurations for its auto operations. This will help selection of volunteers in accordance with pre-specified criteria, screening scheduling and project scheduling etc. The first step toward drug testing is to generate a volunteer database with detailed information. The interface (form) offered is a friendly approach to enter all the basic information. (figure - 1) The allocation of auto volunteer no. makes the indexing sound. The basic information fields are: volunteer name (first, last, middle, auto initials), Age (birth date and auto age calculation), contact information (current and permenant address, tel, fax, email etc.), physical details (height, weight, BMI ratio), medical details (blood group, ref. doctor) etc. Facility is also provided to store and view the image of the volunteer. An image optimisation tool optimises the image size and quality.

		The Main Features of CTVM (VPMS) Volunteer history and profile storage Project configuration Volunteer Screening results Actual Drug Testing reports ADR (Adverse Drug Reaction) reporting Scheduling for screening and Volunteer selections routines Volunteer and Project search facilities Edit verification feature for activity log Activity access rights and locking Volunteer details entry Form
	The second step in the process is to create a project profile and input all the features of the project. This becomes the master file for further project processes and future references. (figure - 2) Project details cover project name, project code, drug code, registration no., volunteer age limits, project dates etc. The necesary screenings are to be selected from the options offered. A user friendly tool is offered here to include a screening or to remove it. Data entry verification is also present to avoid data entry errors.	Drug test Project configuration
	Data entry editing Log An ISO certified company must keep a log of 'why' a change was performed in an entry. This application has the facility to record and report any changes made to any field on any form. As the data is altered and the save button is clicked, a reason box appears for the log file. Reports are available showing the following details: what table was modified, what field was modified, the date and time of the modification, the user name and the reason for the modification.	A Reson Must be given for any Change in a Existing Record (An ISO Requirement)
	The screening data storage form offers user friendly interface with easy to use objects for error free approach. (figure - 4). The entry starts with the projct selection and then the volunteer no selection (at this time the project no field gets locked to avoid any accidental errors). The screening list appears which was configured during project details data entry. On selecting a screening, its details form appears for the numeric and medical reading based data entry. (figure - 5). The other fields provided are behavior details. One more important field is the 'approval for project'. This confirms the availability of the volunteer in the project details form as well as the ADR form. Volunteers' performence is reported in various output tables for reporting.	Basic Volunteer Screenings Results
	Scrrening results entry The results of the screening tests are reported in this form. Subjective information is entered in the text area and the objective entries for positive or nagative result status are inserted as shown. This objective reports will decide the future scheduling and participation of a volunteer. Also when a particular disease study is to be carried out (e.g HIV +ve, drug abuse etc.), the infected volunteers can be easily identified and scheduled. The field of 'pass / fail' decideds if the volunteer is fit for the actual drug test. Only the volunteer with 'pass' status are made available in the next phase of testing.	Detailed Volunteer Screenings Result Entry
	As the actual drug testing begins, there is a change that all the volunteer who have cleared the screening might not show up. The form shown in figure - 6 is used to re-assign the project participation no. to the present volunteers. This form is a grid based approach and shows the initial volunteer no., the participating status and the assigned project participation no. This no. assignment is done after selecting the project code. Once the project is slected is gets locked to avoid accidental errors in participant no. assignement. The application has 3 level identifiers system. These Ids are as follows: - The unique volunteer no. (this never changes) - The volunteer screening no. (this is assigned for each project) - The project participation no. (assigned for a project for approved volunteers) The data is referenced by these Id no. at different stages. The reports carry all these Ids as per the requirement.	Volunteer Participation Status Record
	In case of an ADR (Adverse Drug Reaction) event, a detailed reporting form is offered (figure - 7). The primary selection is the project name and volunteer project participation no. The fileds offered are drug details, dosage, dose peroid, reaction / symptoms details, project continuation status and other comments.	Adverse Drug Reaction Reporting
	The CTVM tool has reports starting from volunteer details all the way till the list of participants successfully finishing the drug test as well as the project statistics and various log of activities for volunteer table, project table, screening table and ADR reports etc. A standard criteria form for seleting the report name is provided as shown in the figure - 8.
	Output Formats
	Many configurations required for the successful operation of this appliation. One of the important is the User creation with Access Rights allocation. The form offers fields for the user name and password as well as the access right category. (figure - 9)