Study Conduct

It is a requirement to register your study on ClinicalTrials.gov before you enroll your first subject and to report results. See Research SOP SC-401: Registration of Clinical Trials in ClinicalTrials.gov and Research SOP SC-406: Results Reporting of Clinical Trials in ClincialTrials.gov for details regarding the process.

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:

• Guidance for Industry Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
• Investigator Manual for IRB Submissions
• UH Investigator Training

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.

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 Responsibility for Study Team Training and Documentation and Investigator Manual for IRB Submissions

Specifics about adverse events and unanticipated (unexpected) problems should be contained in your study protocol. The IRB of record will have specific reporting criteria, but 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 you are both prepared and compliant when they happen.

*See the Investigator Manual for IRB Submissions, Compliance and Monitoring; Reportable New Information. Check out the Clinical Research Toolbox for templates to log adverse events, unanticipated problems, and protocol deviations.

The purposes of monitoring are to verify:

• 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 ClinicalResearch@UHhospitals.org.

*See Research SOP QA 501: FDA Inspections of Investigators, Research SOP QA 502: Monitoring Visits, and Investigator Manual for IRB Submissions, Compliance and 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. Check out the Internal QA Checklists in the Clinical Research Toolbox.

Once all of your study data is collected, you may prepare your study for closure. Be “inspection ready” by reviewing all study materials and performing a final reconciliation before final reporting.

*See Investigator Manual for IRB Submissions, IRB Submission Components, the Study Close Out Checklist, and Internal QA Checklists.

For retention and archive information, refer to UH Policy GM-1 Records Management and UH Research SOP SC 405: Records Retention, Archive and Storage or contact the University Hospitals Clinical Research Center at ClinicalResearch@UHhospitals.org.

Send communication to the Post-Award Management team (UHCRCGrantsAccounting@UHhospitals.org) and provide them with details on the scope of your research project. The Post-Award team will use the information provided to conduct a final reconciliation. This will ensure all clinical bills and study invoices have been generated and reconciled.