Once an adverse event becomes serious, the site should inform the Sponsor by submitting an SAE report. Typically, the Sponsor will provide the report form to use and inform the study investigator/coordinator where and how (i.e. email, fax, etc.) to send the report. An SAE report should be submitted to the Sponsor no later than 24 hours after the site becomes aware of the event. As the site gains more information (i.e. admission records, hospital discharge summaries) updated SAE reports with the new information should be submitted to the Sponsor.

Note: SAEs, Unanticipated AEs, and Unanticipated Problem Involving Risk to Participants or Others must be reported to the IRB within 5 business days as "reportable new information."

The Office for Research Protections Quality Assurance Program conducts directed audits, routine audits and quality improvement assessments. The purpose of routine reviews is to assist investigators with achieving high quality of regulatory compliance. The reviews are meant to be educational and prevent any potential instances of non-compliance. Quality Assurance summarizes and reports the findings directly to the investigators. For more information, go to the Quality Assurance Post-approval Reviews website.

To learn more about the study financial binder, see the information provided by the College of Medicine.

College or unit research administrators assist investigators in maintaining financial records.

According to ICH GCP EC 1.11, a case report form is a printed, optical, or electronic document designed to record all of the protocol required information to be reported on each trial subject. CRFs are designed by the sponsor or sponsor-investigator and maintained at the investigative site. Information documented on the CRF (or eCRF) must be supported by source documentation. At a minimum the CRF should record:

Per ICH GCP guideline E6 section 5.1 source data is identified as “all information in original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.” This is the first recording of subject-related information.

Industry sponsors may provide investigators with a regulatory binder to be used to maintain the essential documents for the trial. Investigators who are conducting investigator-initiated trials are encouraged to use the Penn State's REDCap eRegulatory Binder for electronic storage and organization of regulatory documentation.

“Essential documents are those documents which individually and collectively permit evaluation of the conduct of the trial and the quality of the data produced.

ANNUAL REPORTS TO CDER

For clinical trials being conducted under an IND, FDA requires an annual report from the Sponsor or Sponsor-Investigator. The annual report is due within 60 days of the anniversary date that the IND went effect (i.e., the date that the FDA permitted the study to begin). Required content is listed in 21 CFR 312.33.

ANNUAL REPORTS TO CDRH

REPORTING PROTOCOL DEVIATIONS UNDER IND