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

In many cases Sponsors will specify at the beginning of the study how they would like to handle protocol deviations. Minor deviations (as described elsewhere in this Guidebook) are usually recorded in the case report forms and tabulated by site at the end of the study. Most Sponsors do not require that minor deviations be reported in any immediate fashion. For major deviations the site often reports to the Sponsor are required.

REPORTING UNDER IND (PROTOCOL AMENDMENTS)

You need to submit an IND Protocol Amendment if you have either of the following changes during the course of your study:

The ClinicalTrials.gov Protocol Registration and Results System (PRS) is a web-based tool used to submit clinical study information to ClinicalTrials.gov, which is available to the public.

Study registration is required for some FDA-regulated studies, NIH-funded clinical trials, and for publication in over 1,000 journals.

If registration is required, studies approved by the University Park IRB must be registered prior to IRB approval.

All studies approved or determined exempt by the IRB have reporting requirements over the course of study. For a summary of these requirements, see the IRB webpage on after approval activities. For a more detailed description, see the IRB Investigator Manual.