Protocol deviations are unintentional changes to or non-compliance with the research protocol that does not increase the risk or decrease the benefit or do not have a significant effect on the subject’s rights, safety, welfare; and/or the integrity of the data. For e.g., it can be due to the research subject’s non-adherence resulting in a rescheduled study visit or the Subject’s refusal to complete scheduled research activities, Failure to collect an ancillary self-report questionnaire,etc.
Protocol violations are any unapproved changes or deviations from the study design or procedures of a research project that are under the investigator’s control and that have not been reviewed and approved by the IRB. It can be major or minor depending upon how it affects the patient’s rights, safety or well-being, or the completeness, accuracy, and reliability of the study data. So, as a result, protocol violation can increase the risk and decrease the benefit.
A few examples to understand it clearly are:
Failure to obtain valid informed consent
Loss of data or easy access to identifiable private information about the subjects
Distribution of incorrect medication or incorrect dose
Not following inclusion/exclusion criteria during recruitment of subjects/patients.
What is non-compliance in clinical research?
When any activity is associated with the oversight of research involving human participants that fail to comply with the approved research plan. This repeated non-compliance leads to deviations and can potentially impact the trial subject’s safety or rights or the data credibility.
According to the FDA inspections of clinical trials, a few common non-compliance and GCP violations are:
- Compliance with Protocol: A most critical part of clinical studies. Too many deviations, and waivers without any proper documentation and approvals from sponsors. A common finding enrolment of ineligible patients.
- Informed Consent: Lack of EC-approved consent, use of understandable language to the subjects, and adequate documentation of the entire process.
- Source Document: Confirmation for diagnosis according to inclusion and exclusion criteria. Investigator’s involvement and documentation of adequate information of the study process following the study protocol. The most important aspect of documentation is confidentiality, reliability, and secured date keeping.
- IMP: Investigational drug storage condition, accountability, and accessibility are crucial and should be recorded contemporaneously and proactively monitored.
- Adverse Events: All the AE and SAEsshould be documented and reported within the timeline. This is the most critical part of any clinical study which can impact the study result.
Hence, the point which should be emphasized here is that compliancein clinical research should be maintained. And the responsibility of all the stakeholders during the clinical study should aim to protect the rights and welfare of the patients.
Why GCP is important in clinical research?
It improves ethical awareness, trial concept, market competitiveness, data quality, and safety of trial subjects. It will be achieved successfully by the equal involvement of the Investigator, Sponsor, Ethics Committee, and Monitor.
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