Clinical Trial Audit Preparation Checklist

Clinical trial audits are an integral component of maintaining data integrity and regulatory compliance, so having an independent third-party conduct audits could save you from receiving adverse findings from the FDA.

This checklist covers the key aspects auditors look for when reviewing investigator site files (ISFs). Additionally, it can serve as a useful way of self-monitoring ISF documents on an ongoing basis.

1. Review the Study Protocol
A research protocol should include an in-depth description of the study. This should include clear statements regarding review questions, inclusion criteria and data extraction methods(s).

Research teams should also outline their plans to address any weaknesses or limitations found in previous studies, to ensure a thorough and meaningful review is conducted.

Research protocols should also outline a quality control and assurance system to conduct trials successfully, such as Good Clinical Practice (GCP), clinical monitor follow up by clinical monitors or data security management board (DSMB), data storage management board (DSMB), as well as data management.

2. Review the Study Documents
Clinical trial audits come in various forms. From system audits without direct reference to any particular trial; or state supervisory agency-conducted inspections specifically targeting an issue related to admissibility or credibility of one trial; these audits offer multiple perspectives of review for your clinical trial experience.

Auditor’s in the latter case will compare CRF data with source documentation such as medical records such as X-rays or electrocardiograms, laboratory results, patient self-assessments/diaries/pathology reports etc. In addition, auditors will ensure the underlying assays can consistently produce consistent results.

Research sponsors and FDA do not have the resources to inspect every clinical trial site, so they must select which trials to audit. In general, audits tend to target sites with higher rates of adverse events (ADEs) and protocol violations.

3. Review the Study Records
An auditor will inspect site records in this phase to ensure that the trial is being run accurately, such as informed consent documents, appointment books/logs/pharmacy agreements/medical records/screener logs etc.

These records should then be thoroughly assessed for accuracy to identify any patterns of noncompliance that could negatively influence the results of the study and correct these errors before finalizing a CSR.

Documenting compliance practices and protecting the integrity of research is paramount to remaining compliant, including archiving and disseminating record review findings.

4. Review the Delegation Log
A delegation log should record those study staff members assigned significant study-related tasks by their PI, and should be updated whenever there is a change in roles or duties.

Due to staff turnover or reassignments, original task assignments may no longer fulfill their intended purposes for the duration of a study. Therefore, it is imperative that PIs ensure any gaps are filled by qualified individuals as soon as possible and also verify whether all personnel listed have received necessary qualifications and training in order to carry out their assigned responsibilities effectively.

5. Review the Study Schedule
Schedules can play a critical role in helping participants receive therapy at the appropriate times, which is especially true for clinical trials that include complex medication regimens.

Sponsors often request the visit schedule so they can confirm that visits are occurring according to protocol-specified timeframes, an essential step that often gets missed.

Reviewers evaluate documentation such as appointment books, sign-in logs and screening lists. Furthermore, this review compares lab results against source documents while verifying accreditations, credentials and staff training are in order.

6. Review the Study Reports
An independent audit is vital in helping clinical sites maintain complete, compliant documentation of trial processes and interactions, as well as identify any procedures which need improvement. If documentation gaps remain unfilled, for-cause inspections or even Form FDA 483 could ensue.

ISFs (Investigator Site Files) serve as the central repository for all information pertaining to any trial, from consent documents and medical records, source documents, correspondence and documents relevant to it, etc.

7. Review the Study Data
Auditor’s review data to ensure its accuracy and completeness; additionally they ensure all required reports have been filed.

Audits are crucial in order to ensure the trial is being carried out according to its protocol and that inaccurate or missing data does not lead to delays, or worse yet invalidate it altogether.

Additionally, this section of the audit involves reviewing a delegation log to ensure only appropriate personnel are conducting the research – this includes validating both the Principal Investigator’s (PI) and staff members’ medical licenses for duration of study.