Protocol Management

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(Protocol Admin)
(Baseline Data)
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===Baseline Data===
===Baseline Data===
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Enter baseline data for this patient.
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Enter baseline data for this patient. This interface is a specialized dynamic eform/workflow (Table: MetadataEForms) with the eform name "Baseline".
===Schedule===
===Schedule===

Revision as of 13:40, 2 November 2010

Contents

Protocol Management

Documentation for the Protocol Management module is in progress.

Protocol List

The main entry point for the Protocol Manager, the protocol list contains a list of all active Protocols as well as the number of Treatment Arms/Schemas per Protocol.

Protocol Patient List

Lists all Patients currently assigned to the Protocol (including Failed screenings). This list can be filtered by Treatment Arm or Patient Protocol Statuses.

Protocol Patient Calendar

A calendar view of the schedules of ALL Patients on a Protocol. The schedules can be viewed month by month basis, allowing the user to view past and upcoming visits. This view can be filtered by Treatment Arm.

Protocol Admin

Administer a Protocol by adding/editing Protocol information, versions, treatment arms and eligibility. The section allows a Protocol Admin to edit a protocol by giving access to add new versions to a Protocol, as well as new treatment arms.

Protocol Versions

Each Protocol may have multiple versions, in which each versions may have multiple Treatment Arms.

Eligibility Questionnaire

For each Protocol Version, there is an associated Survey (Table: MetadataSurvey), which controls the generation of the eligibility questionnaire.

Treatment Arm

Each version of a Protocol may have multiple treatment arms. The treatment arm is where the Admin will define the items which are collected during a visits as well as the schedule of the trial.

Treatment Arm Info

Define the title as well as max patient accrual (optional).

Items

Defines the visit and which data entry items are collected during the visit. The Admin can choose which fields are collected, default values as well as if items should appear as data grid (for collecting multiple data entry items).

Timeline

This is where the Admin will define how many visits will occur and what items will be collected at each visits. This allows the Admin schedule items in any combination of intervals such as Days, Weeks and Months. Visits can also be marked as recurring, which will generate visits for x weeks.

Protocol Patient Portal

After a Patient has been successfully screened for a Protocol, the Patient portal will be available to enter trial details for the specific patient. Any details relating to a patient's statuses, eligibility, visit information, will be viewable from this interface.

Summary

View a summary for this patient, including current status and recent and upcoming items.

Patient Statuses

List of all of a Patient's status for a Protocol (sorted by date ascending). Statuses will correspond to various stages in the registration process, such as eligibility and consent.

Patient Visits

Lists recent and upcoming visits for a Patient. Clicking on a visit navigates to data entry for that visit.

Registration

View and edit information regarding patient screening, consent, and registration.

Eligibility

Enter eligibility questionnaire for this patient. The questionnaire is a special Survey (MetadataSurvey) which is used for determining the eligibility of a Patient. Answering ineligible to a question does not restrict a Patient from being scheduled for the trial.

Baseline Data

Enter baseline data for this patient. This interface is a specialized dynamic eform/workflow (Table: MetadataEForms) with the eform name "Baseline".

Schedule

View scheduling calendar for this patient. This interface allows the user to navigate each month of a Patient's scheduled visits. Data entry items are lists on days which the Patient is scheduled. Clicking on these items will directly link to the date entry for that visit.

Patient Visit

Update statuses and enter data for patient visits.

Response

Track patient response data for this patient.

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