Requirements

• Blank set of CRFs, data collection sheets, and IRB-approved study questionnaires
• Refer to website link (see below) for guidance to ensure appropriate source documentation

FAQs

Q: What is the difference between Case Report Forms (CRF) and Data Collection Sheets?

Data collection sheets typically act as source documentation. That is, during study visits, information is written directly onto the worksheets. An industry sponsor usually provides CRFs; all protocol-required information is transferred to CRFs from data collection sheets. Some studies do not use CRFs. All studies should use some type of data collection sheet.

Useful Links

Source Documentation: Principal Investigator Responsibilities:

http://healthcare.partners.org/phsirb/PI_Responsibilities.htm