It is common practice for investigators to delegate certain study-related tasks to employees, colleagues, or other third parties (individuals or entities not under the direct supervision of the investigator). However, the Principal Investigator (PI) is ultimately responsible for the conduct of the study. When tasks are delegated by an investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated. A Delegation of Authority log should be created documenting delegated tasks to delegated individuals.

The Bioresearch Monitoring Unit of the FDA may conduct inspections of medical research and testing facilities in order to ensure studies avoid bias and follow proper testing procedures. The FDA inspector will review all case study data and may interview subjects and doctors. In all types of inspections, an FDA inspector checks the study for errors that affect the outcome. Investigators may expect the following types of inspections:

Prepare for an Audit

An audit is a systematic and independent examination of trial-related activities and documents to evaluate whether the trial-related activities were conducted and the data were recorded, analyzed and accurately reported according to the protocol, Sponsor’s SOP, GCP and other applicable regulatory requirements. Auditors collect evidence and compare against standards, review documents, assess deviations and non-compliance and recommend actions.

IND SAFETY REPORTS

In cases where the PI is both the Investigator and the Sponsor, the PI assumes the responsibility of reporting certain SAEs to the FDA and IRB. Once it is determined that an SAE must go to the FDA an IND Safety Report is prepared (usually the PI, in association with the medical monitor, will determine whether an IND Safety Report needs to be prepared). An IND Safety Report is an expedited, written notification to the FDA of an adverse experience associated with the use of a study drug that is both serious and unexpected.

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.