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 within 21 days of 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.