Compliance keys for drug studies

The Philadelphia-based University of Pennsylvania's office of human research has developed research compliance tools and templates to assist investigators in adhering to Good Clinical Practice. Below are sample items from the study administrative file for drug studies, which are reprinted with permission from Gregg J. Fromell, MD, executive director of the office of human research:

Laboratory Documents

• Laboratory Certifications and Licenses

- Required for studies utilizing laboratory data or results

- Provides evidence of the competence of the facility to perform the required test(s) and supports the reliability of the lab results

- UPHS certifications may include: the state laboratory license/permit, an accreditation by The College of American Pathologists (CAP), Clinical Laboratory Improvement Amendment Accreditation (CLIA), and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), CV of laboratory license holder

- For HUP Lab certificates, call (this number)

• Normal Reference Ranges

- Laboratory reference ranges may vary from laboratory to laboratory; therefore it is necessary to include documentation of the laboratory's normal range values. All updates to the laboratory ranges must also be maintained.

- For HUP lab normal reference ranges, call (this number).

• Lab Manual(s), if applicable

Checkboxes:

- Current Lab Certification

- Lab Manual

- Current Normal Lab Ranges

- CV of Lab Director (local)

- Record of Retained Samples.

Monitoring

• Monitor Signature Log and Visit Record

- Tracking document that records the visits made by the monitor throughout the course of the study

• Study Initiation Reports

- Letter documenting that the procedures were reviewed prior to study initiation and the site was determined to be suitable for enrollment

* Interim Monitoring Reports

- Letter documenting the findings after each monitoring visit

• Close-out Report

- A report or letter documenting that the study had a final monitoring visit after the conclusion of the study to ensure any outstanding issues have been resolved

• Monitor Curriculum Vitae (CV)

- If monitor is hired by the PI, a copy of the monitor's CV

Checkboxes:

- Monitor Signature Log and Visit Record

- Study Initiation Report

- Interim Monitoring Reports

Report from visit date:

- Close-Out Report

- Monitor's CV (or Not Applicable).