DATA-103 (formerly QA-706): Case Report Form (CRF)

DANA-FARBER / HARVARD CANCER CENTERSTANDARD OPERATING PROCEDURES FOR HUMAN SUBJECT RESEARCHTITLE: Case Report Form (CRF) Submission Compliance for PI-Initiated ProtocolsSOP #: DATA-103 (formerly QA-716) Page: 1 of 3 Effective Date: 9/17/121. POLICY STATEMENT:The Quality Assurance Office for Clinical Trials (QACT) Data Analysts monitor thecase report form submission compliance for PI-Initiated protocols managed by theQACT.2. BACKGROUND:Case Report Forms (CRFs/eCRFs) contain clinical and other pertinent data collectedduring the trial process and represent the official documentation of trial resultsprovided to the sponsor and regulatory authorities. CRFs allow study information tobe recorded, handled, and stored in a way that allows its accurate reporting,interpretation and verification.3. RESPONSIBLE PERSONNEL:3.1. Sponsor3.2. Overall Principal Investigator (PI)3.3. Study Coordinator3.4. QACT Data Analyst4. DEFINITIONS:None5. PROCEDURE:5.1. This policy applies to all protocols for which the QACT Data Analysts areresponsible, regardless of whether the protocol is monitored by the DF/HCCData Safety Monitoring Committee (DSMC)/Data Safety Monitoring Board(DSMB). For protocols that are monitored by the DF/HCC DSMC, theprocedures here may be augmented or superseded by those found in the DSMCdata submission compliance policy.5.2. The QACT Data Analyst develops a protocol specific missing form report usingthe QACT missing form report template, the protocol guidelines and the timepoints on the CRFs for submission requirements.5.2.1. CRF/eCRF set up lead time: Missing form reports will be generated within1 month after the finalization of CRFs/eCRFs.

DANA-FARBER / HARVARD CANCER CENTERSTANDARD OPERATING PROCEDURES FOR HUMAN SUBJECT RESEARCHTITLE: Case Report Form (CRF) Submission Compliance for PI-Initiated ProtocolsSOP #: DATA-103 (formerly QA-716) Page: 2 of 3 Effective Date: 9/17/125.3. The QACT Data Analyst sends the missing forms report on the followingschedule:5.3.1. PI-Initiated trials: Missing Form Reports are sent quarterly to the Sponsor,Overall PI and Lead site study coordinator.5.3.2. PI-Initiated Multi-center trials: Missing Form Reports are sent monthly tothe Sponsor, Overall PI and Lead site study coordinator.5.4. At the time of DSMC notification, the Data Analysts will notify the Sponsor,Overall PI and Lead site study coordinator when the percentage of missing formsis not compliant with the DSMC data submission compliance policy.5.5. It is the responsibility of the Sponsor and Overall PI to monitor the datasubmission compliance of all sites participating on the trial within and external toDF/HCC. The distribution of the missing forms reports may be delegated by theSponsor to a qualified individual on the study team.5.6. Within 1 week of receipt, the Sponsor, Overall PI and Lead site study coordinatorshould review the missing forms report and notify the QACT Data Analyst inwriting of any discrepancies noted. The QACT Data Analysts will work toresolve the discrepancies if programmatic issue exist and will resend the updatedreport. This process is repeated until there are no further disputes as to theaccuracy of the report.5.7. The QACT Data Analysts maintain data compliance information.6. APPLICABLE REGULATIONS & GUIDELINES:21 CFR 50 – Protection of Human Research Subjects21 CFR 54 – Financial Disclosure by Clinical Investigators21 CFR 56 – Institutional Review Boards21 CFR 312 - Investigational New Drugs – Drugs for Human Use21 CFR 812 - Investigational Device Exemptions45 CFR 46 – Protection of Human SubjectsFDA Industry Guidelines and Information SheetsFDA Compliance Policy Guidance Programs: 7348.809, 7348.810, and 7348.8117. RELATED REFERENCES:International Conference on Harmonisation – E6

DANA-FARBER / HARVARD CANCER CENTERSTANDARD OPERATING PROCEDURES FOR HUMAN SUBJECT RESEARCHTITLE: Case Report Form (CRF) Submission Compliance for PI-Initiated ProtocolsSOP #: DATA-103 (formerly QA-716) Page: 3 of 3 Effective Date: 9/17/128. RELATED FORMS & TOOLS:NoneVersion: 2Effective Date: 9/17/12Last Reviewed Date: 2/28/12