eProtocol

Medical Regular Form

Upgrade

Research Compliance

StanfordUniversity

For information, contact:

Kathleen Garcia:

723-5481

 Email ID:

Requirements

Overview

Target Date for Test: June 16th

Creating the Protocol

Protocol Title

  • New text area added above the Protocol Title entry box. This area will be used for instructions, etc. and letting the users know what to expect, etc.
  • Needs to be updateable by staff (Kathleen)
  • Needs to handle HTML (bulleted lists, font color/weight changes)
  • Needs to be dynamic – no text: no need to show gap on page; Text – adjust window accordingly
Personnel
  • New text area added.
  • Bread-crumb title should be Personnelas shown above. Currently, it displays as Create Protocol.
Application Category/Type

  • New text area added with a sample of possible text shown above.
  • Bread-crumb title should be Application Category/Type as shown above.
  • Heading over entry area should read Application Category/Type as shown above. Currently, it shows as Decision.

Personnel Info

  • A new text area is added at the top of page.

Participant Population

  • A new text area is added at the top of page.
  • Heading title changed to read Participant Population(s) Checklist.
  • The left-hand menu option changed to read Participant Population.
  • The first item on the checklist should read Children (under 18).
  • Also, the answers provided will now be used to drive the behavior and display of other parts of the form. This will be described later in the form when applicable.

Study Location

  • New text area added at top of page.
  • Labels for items updated – see above.
  • Added a new table to allow for entry of details for multiple other locations. See below for pop-up entry window. The otherbox must be checked in order to ADD other locations.

General Checklist

  • Questions grouped and listed under different headings, in a different order. The XML value_id for the location where the responses to questions are currently stored is shown in red.
  • The former VA Checklistquestions are incorporated into this General Checklist. There will no longer be a left-hand menu option for VA Checklist.
  • Added a new table to allow for entry of details for cooperating institutions related to multi-site studies. See below for pop-up entry window. The YES must be selected for multi-site in order to ADD cooperating institutions.

Funding

  • Change main label name to Funding. Previously it was Funding Checklist.
  • Add new text area above.
  • Move the NONE checkbox up to the top as shown above.
  • Remove the NOTEtext at bottom of page (info will be provided by text area above).

Resources

  • This is a new page that need only be stored in the XML.
  • The left-hand menu option should be called Resources and is located in the same place where the VA checklist menu-option was previously located.
  • The text area at the top of the page should behave like all of the other new text areas previously mentioned.

Protocol Information

1 – 3. Purpose, Study Procedures, Background
4. Radioisotopes or Radiation Machines

No changes for this section.

5 – 6. Devices, Drugs, Reagents, Chemicals
Page 5 - 6
  • What was formerly Investigational Devicesnow becomes Devices.
  • Devices sectionis #5. Medical Equipment has been moved to later in the form.
  • Devices sectionnow has two sub-sections: Investigational and Commercial.
  • The pop-up windows for entering data for Investigational and Commercial devices are shown below.
Investigational Devices
Commercial Devices
Investigational Drugs
Commercial Drugs
7. Devices, Drugs, Reagents, Chemicals
8 (a – g). Participant Population
8 (h – m). Participant Population
9 (a – e). Risks
9 (f). Risks

Stanford UniversityPage 1 of 26

eProtocol-medical-reg-upgrade.doc06/01/2006