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FDA Guidance for Investigator Responsibilities

In October 2009, the FDA released a procedural document reminding of the importance of Investigator responsibilities in regard to the rights, safety, and welfare of human research participants. The non-binding recommendations loosely outlined the areas that any research investigator should scrutinize carefully and the steps that they can take to conduct their studies within the perimeter of FDA compliance.

As part of Quorum's desire to provide relevant information to its clients in the area of clinical studies, we are providing a primer in this article to show the broader points that the FDA referenced in its document. For more detailed information, be sure to contact the FDA for a copy of their guidance materials.

What are the basic investigator responsibilities?

• ETHICAL CONDUCT: The investigator ensures that the clinical investigation is conducted according to the agreement with the sponsor and/or IRB and all regulations that apply. He or she also agrees to supervise the testing of investigational drugs or devices, or to properly supervise the qualified study staff members who may have such tasks delegated to them. It is important to remember that the investigator can be held accountable for regulatory violations committed by their staff or for failure to supervise their study staff appropriately (in a way that affects study participants or how the study is carried out). Safety reports should be filed in a timely manner, and study records should be maintained with the utmost accuracy.
• PROTECTION OF PARTICIPANTS: The investigator makes every reasonable effort to protect the rights, safety, and welfare of the subjects under the investigator's care. This includes (but is not limited to) making sure that medical care is available for any adverse events that may occur. If the investigator is not qualified to provide this care, they must make arrangements with a qualified provider to handle these events should they happen. An investigator should also communicate openly with a study participant about medical conditions that can arise during a study – possible side effects of the study drug/device or any procedures associated with the study, probability of allergic reactions (if applicable), etc. Protection duties also encompass following the protocol procedures and timelines accordingly. Tests identified within the protocol should be done within the specified timeframes to not only relay correct research data, but to have participants monitored for adverse events.
• CONTROL OF THE STUDY PRODUCT: The investigator makes every reasonable effort to control the investigator-to-participant distribution and the research site storage methods of drugs under study (including biological products and devices). Study drugs or applicable study devices should not be given to participants who have not read and signed the informed consent document (either themselves or via a legal authorized representative), or those have been removed from the study by the sponsor or those who have revoked their consent. This control should also be considered applicable to possible rescue medications that may be given concurrently with study drugs or devices.

For more information on investigator responsibilities, please read Federal Regulations 21 CFR part 312 and 21 CFR part 812.