Requesting a 21 CFR Part 11 Validated Project Instance

Initial Considerations

This guide describes the process & steps needed to request a REDCap, 21 CFR Part 11 Validated project.

21 CFR Part 11 Compliance enforces provisions which requires that:

• Study personnel develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks.

• Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures

Cost Factors

Note: There is a fee associated with use of REDCap for a 21 CFR Part 11 validated project instance whether you build the project on your own or if BMIC project assistance is needed.

• Self-built Validated projects require a flat-fee journal entry

• Validated projects which will be built by the BMIC team require the flat-fee charge, plus additional project build fees as determined by a statement of work and project design.

• Projects NOT requiring 21 CFR Part 11 compliance under FDA regulations or sponsors requirements do not have this associated fee and should not be requested as a 21 CFR Part 11 REDCap project.

  • For instance if your general research project is using econsent for non-FDA regulated study and has no sponsor requirements for 21 CFR Part 11 compliance, no additional validation fee is required.

The Process

1. Register project in: Protracks System

2. Select the below services:

   1. Biomedical Informatics Core (REDCap Project Request)

   2. Biomedical Informatics Core (21 CFR Part 11 Validated Request)

      Open

      

3. To complete the initial registration process for [validated projects] there will be total of 3 ProTracks forms which need completed (they will sequentially appear in the ProTracks registration process):

   1. CTSI Services Requested

   2. CTSI Project

   3. BMIC Project Information

4. Upon selection of [21 CFR Part 11 Validated] service, a BMIC help ticket will be automatically generated for your project in the BMIC REDCap Service Desk

5. The BMIC team will then review your request & schedule a meeting to proceed

6. Upon completion of meeting, 2 survey(s) will be sent to study personnel for completion:

   1. Work-auth form to capture details for flat fee / project build (as applicable)

   2. PI sign-off & acknowledgement of REDCap Validated instance requirements & approval of project recharge fees

7. After PI Sign-Off is captured, the BMIC team will communicate with key personnel using the BMIC Help ticket to perform the below tasks (as applicable):

   1. Approve creation of study teams Validated Developmental project

   2. Proceed with next steps for [BMIC built] project

Additional Considerations