Conducting Your Own QA Reviews

Consent Forms & Essential Documents

Amy Rovitelli, MS, CHRC Sr. Regulatory Coordinator

James P. Wilmot Cancer Center

QA Reviews at a Glance O Why conduct self-reviews?

O A good way to ‘check the pulse’ of your research program.

O Easier to correct errors real-time than months later.

O Discovering and correcting errors early can prevent repeated errors in the future.

O Decreases staff stress level if study is chosen for an audit.

Topic Overview O Consent forms

O Common errors O Introducing a self-review tool

O Essential Documents

O What do I need? O Using ICH GCP guidelines to create a user-

friendly tool

Common ICF Findings O Missing letterhead or watermark O Wrong ICF version used O Ink signatures or dates incomplete or illegible O Dates incorrect or do not match O Lack of IRB approval or delegation of staff

member performing consent discussion. O Errors not corrected properly O Missing checkboxes or initials for procedures

Using Common Errors to Create an ICF Compliance Tool

Original document with letterhead & watermark present: Yes No

Correct version of ICF document used: Yes No Version date: Date signed:

Expiration: or N/A Subject signature and date/time

As specified (ink, complete and legible): Yes No

Investigator/designee signature and date/time As specified (ink, complete and legible): Yes No

Witness signature and date (if applicable)

As specified (ink, complete and legible): Yes No N/A

Do signature dates match? (All must be same date): Yes No

Using the ICF Tool O Initial reaction to tool:

O Going to be time consuming. O Extra work.

O 6 months after using tool:

O Noticeably fewer errors found over time! O Saves time when study chosen for

audit/review O Worth the effort

Essential Documents O What do I need??

O FDA Good Clinical Practice 2013 Reference Guide (Current: April1, 2013-March 31, 2014)

O Depends on the study (GCP Section 8)

O Clinical Drug Trials O Industry vs investigator-Initiated

O Who’s holding the IND? O Non-Drug Interventions O Lab studies

ICH GCP Essential Document Checklist

Study Number: _______________________________ Status: Pre-Activation; Active Study; Closing

Study Type: Clinical Drug Trial; Non-Drug Subject Research (ICF); Non-Drug Research (No ICF)

Usual Regulatory Binder Items: Location of Document (if/when applicable) date:

Section Numbers Document Not

Applicable

Regulatory

Binder

Coordinator

Manual

Other

Location

8.3.20 Subject Screening log

5.5.5, 8.3.21 & 8.4.3 Subject ID code list

8.3.22 Subject enrollment Log

8.3.12 Signed ICFs

8.2.2 & 8.3.2 (Signed) Protocol & Amendments

5.5.2 Data Safety Monitoring Plan (if applicable)

8.2.7, 8.2.9 & 8.3.4 IRB approval

Pre-activation requirements, Active study requirements, Study closure requirements, Other required documents.

Using the Essential Document Tool

O Existing Studies: O Useful for QA review to be sure all required

documents are included O New Studies:

O Useful for new coordinator to help with binder set-up

O Useful for coordinators managing new types of research with different requirements.

Creating & Modifying On Your Own

O Create new or modify existing tools to suit your department needs

O Use available reference materials or common error lists to help develop your tools

O Keep tools simple O Cumbersome & wordy tools are less likely to be used

regularly.

O Ensure staff are trained on use of tools O Review & revise tools as needed per current

regulations

Questions?