Study Conduct

Investigator Responsibilities and Oversight

Principal investigators are responsible for the overall conduct and oversight of the research study and should be familiar with the federal regulations governing the conduct of human subjects research. Following are some resources to help:

It is the PIs responsibility to ensure that an investigation is conducted according to:

  • Study protocol
  • IRB requirements
  • All applicable federal, state, and institutional regulations

The PI must also personally conduct the study or supervise the aspects that are delegated.

Protocol Compliance

It is important to follow your Institutional Review Board (IRB) approved protocol as written. Providers are trained from the very beginning to use their judgment and make decisions that are best for their patient. In research, providers must follow the protocol. The only time it is acceptable to deviate from the protocol is when there is a risk to your study patient’s safety. Many investigators have both clinical roles and responsibilities in addition to research roles and responsibilities; often it can be challenging to wear both hats simultaneously. Be aware of this when making decisions and ask for help or a gut check when you need it. Creating thorough source documents at the beginning of the study will keep the study team on track with protocol compliance.

If you realize that you need to make changes to your study, modify your protocol and submit these changes to the IRB for review. Once the IRB approves them you can implement the changes. DO NOT implement changes to the research prior to IRB approval unless there is a study patient safety issue. Report study patient safety issues promptly.

If the protocol is amended there may also be a need to amend the contract, coverage analysis, source documents, case report forms or other study materials.

Once changes are approved by the IRB, retrain the study team on the changes and document this in the training record.

*See UH Research SOP GA 105: Investigator Responsibilities for Study Team Training and Documentation and UH IRB Policy Event Reporting

Adverse Events, Unanticipated Problems and Protocol Deviations

Specifics about adverse events and unexpected problems should be contained in your study protocol. The IRB of record will have specific reporting criteria, your study sponsor may have different criteria as may any funding agency. Find out at the beginning of the study what the expectations for reporting are, so that you are both prepared and compliant when they happen.

*See UH IRB’s policy IRB Policy, Event Reporting: Unanticipated Problems, Adverse Events and Protocol Deviations and FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection and FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

Quality Assurance (QA) and Monitoring

The purposes of monitoring are to verify that:

  • The rights and well-being of human subjects are protected
  • The reported study data are accurate, complete and verifiable from source documents
  • The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s)

The study sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s).

If you are the sponsor of your own investigator initiated study, then you are responsible for ensuring that your study is monitored. For help identifying a monitor for your investigator initiated study, email .

*See Research SOP QA 502: Monitoring Visits, Research SOP QA 501: FDA Inspections of Investigators and IRB Policy, Monitoring.

After you enroll your first subject, perform a quality check:

  • How did it go?
  • Were there any barriers?
  • Check in with the team. Review the data entry after the first subject.
  • Did every data point match up?
  • Does anything need to be changed in the next study visit or the next first study visit?
  • Is re-education needed?
  • Any deviations need to be reported?
  • Develop a mechanism to spot check periodically to make sure everything is working well.
IRB Continuing Review and Other Annual Reports

IRB Review is typically required annually but check your initial approval letter for details. If the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, all research activities must stop.

*See IRB Policy, Protocol Continuing Review. If you submitted your study to the FDA, then annual updates will also be required. See FDA 21 CFR Part 312 and 812 for details or contact the Regulatory and FDA Support Core.