Human Study Operational Management

Investigators are required to conduct studies that comply with applicable federal, state, and local regulations. These regulations are important because they ensure the safety of study participants and quality of the data, which will potentially be used to make decisions on the approval or disapproval of a future . Principal investigators must be aware of their responsibilities because they have final accountability for all aspects of a research study at the university, state, and federal levels. This includes oversight of any other personnel to whom study responsibilities have been delegated responsibilities.

• Office of Clinical Research - Principal Investigator Responsibility Policy And Procedure
• Office for Human Research Protections Investigator Responsibilities FAQs
• Food and Drug Administration Guidance Document Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects 
• [Possibly include investigator responsibility interactive slides]

The Office of the IRB ( OIRB ) administers the self-assessment program as part of the IRB quality improvement program to better the human research protections at the UTHSA. The self-assessment program provides an opportunity to educate investigators and research staff on federal, state, and UTHSA regulations and policies in the area of research recordkeeping; assist investigators in assessing their own programs; and assist the OIRB / IRB in identifying areas on which additional institutional educational programs may need to focus. PIs will periodically be required to complete the self-assessment near the end of the current approval period for one of their studies; only non- identifiable individual and aggregate data is seen by the IRB. PIs seeking to improve their research operations may also choose to voluntarily complete the assessment instrument to identify areas for potential improvement. More information on the PI Self-Assessment Program may be found in the PI Self Assessment Program Policy and Procedure

Good records are essential for verifying the quality of study data produced, confirming protection of participant rights/welfare, and demonstrating investigator compliance with regulations, laws and institutional policies.  UTHSA investigators must retain research records in accordance with federal, institutional, and sponsor requirements.  The regulatory mandate for records retention depends upon which regulations are applicable to the research.  For some documents UTHSA requires much longer retention than some federal requirements.  Investigators must comply with all applicable requirements.  More information on the institution’s records retention policy may be found here: 
UT Health Records Management and Study Documentation Standards Policy.

Research conducted at UTHSA is subject to audits by the UTHSA Institutional Compliance and Privacy Office and other regulatory entities.

The primary goal of an audit is to evaluate a research project to ensure the rights and welfare of human research participants are protected and that the research complies with federal regulations, state laws, and institutional policies. Audits are performed routinely for surveillance purposes; notification of an audit does not necessarily indicate a suspicion of wrongdoing by the investigator or study team.  UTHSA maintains an internal audit program and also provides support when an external entity conducts an audit of a UTHSA research study. If you have received a notification that your research site will be inspected by an external entity, notify the Compliance office so representatives can assist you in the preparation. 

Learn more about how internal audits of human subjects research are conducted in the Study Reviews for Human Research policy.

Different entities may also audit or inspect research studies, including external sponsors and federal agencies such as the Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP). Any clinical research site may be chosen for an audit or inspection, but inspection might be more likely if your site stands out from other sites in the study in some way, such as high or low enrollment , high or low response to the treatment, many withdrawals, many adverse events or protocol violations, or frequent data outliers. Sites where the PI is conducting many studies, working outside his or her specialty, or where there have been problems identified at previous inspections are also more likely to be selected.

Most audits, regardless of type, generally follow a similar set of steps:

1. Site notification: notification that an audit will be conducted, with details of when, where, who, and what. Notice of an impending inspection may be given only a few days in advance. Inspections may also be unannounced.
2. Site and auditor preparation: The time between notification and the auditor's visit should be used to prepare by ensuring all records are available and organized for the auditor. The auditor will review available study information (protocol, amendments, etc.).
3. Site visit: The auditor meets with appropriate research team members for orientation to the records and processes; reviews the specified research records; interviews involved staff; and asks questions. . If possible, host the inspectors in a dedicated room or area such as a conference room, where the inspector will not have access to information outside of the scope of the inspection. Always be polite, but limit conversation to answering questions only. If you do not know the answer to a question, offer to find out—do not speculate on what the answer might be. A closeout meeting with appropriate study staff is conducted during which findings are discussed and the research team is encouraged to ask questions.
4. Audit report: A report containing any findings is sent later, at which time a response is usually required. As a result of an audit, most studies will have at least a few items requiring some amount of attention. Any issues related to protocol deviations or noncompliance should be handled according to institutional policies and procedures. OIRB staff can guide you in reporting these issues if they arise.

Information about FDA inspections can be found in the guidance document “Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors FDA Inspections of Clinical Investigators”

Information about OHRP compliance oversight procedures can be found in “Compliance Oversight Procedures for Evaluating Institutions (2009)”

ClinicalTrials.gov records require the following maintenance:

• Current Status Updates - must be updated at the time they occur
  • Examples:  enrollment status, anticipated or actual dates, completion dates
• Annual Updates - at least once a year
• Posting of the Consent Form – must be posted after recruitment closes, and no later than 60 days after the last study visit.
• Results Reporting –within 12 months of the primary completion outcome date (for applicable clinical trials)

link to OCR INSTITUTIONAL REQUIREMENTS FOR REGISTRATION OF CLINICAL TRIALS policy

Contact Karen Nijland, BPharm, RPH in the Office of Clinical Research (OCR) at (210) 567-8554 or nijlandk@uthscsa.edu for further assistance.