Other responsibilities of Principle Investigators

In addition to the responsibilities just reviewed, it is also necessary that you, as the Principal Investigator, have detailed knowledge of the disease process under study, protocol and medication that is being investigated.

Furthermore, you must have qualified study staff and the necessary resources available to execute the trial as outlined in the protocol. This also includes sufficient time, appropriate storage facilities, as well as having a sufficient patient population that will allow you to meet the timeline requirements of the protocol.

Good Clinical Practices mandate that sponsors conduct routine monitoring of all investigative sites.  The purpose of monitoring is to verify that the rights of subjects are protected, and reported trial data are accurate, complete and verifiable from source documents. The CRA will also verify that the conduct of the trial is in compliance with the approved protocol and amendments, regulatory requirements and Good Clinical Practice.

Your site may also be chosen for a routine audit.


You must also be aware that your clinical trial site may be inspected by a regulatory authority. Inspections can occur during an ongoing trial, or after completion of the trial. Ethics Committees may also inspect your clinical trial site to ensure that studies are conducted in compliance with the protocol and GCPs.

If you receive notification of a regulatory authority or Ethics Committee inspection, please notify your CRA as soon as possible. Your CRA will provide guidance regarding Merck’s expectations of your communication prior to, during, and after the inspection. We will also provide you with a contact name and number that you may utilize during the inspection as needed.  Attached to this learning module is a document entitled ‘Tips: Preparing for an Audit’ that you may find beneficial to review. If you are notified that your study site will be inspected, this document will be provided to assist you with preparing for the inspection process.

All monitoring, auditing and inspection activities may involve the review of individual subject data, and regulatory documents, including correspondence with the Ethics Committee and Merck's study team.  By organizing and maintaining your study documents throughout the course of the study, you will be better prepared for such inspections.