Clinical trials carry significant responsibilities. Both sponsors and investigators must ensure trials proceed ethically, safely, and in full regulatory compliance.
Without clear adherence to compliance standards, research risks participant harm, data invalidation and regulatory sanction.
Understanding Roles and Legal Responsibilities
Sponsors take overall legal responsibility for initiating and conducting a trial. Investigators, meanwhile, manage the day-to-day conduct of a trial site and must ensure the protocol is followed.
In Kenya, the Pharmacy and Poisons Board (PPB) enforces the rules under the Pharmacy and Poisons (Conduct of Clinical Trials) Rules, 2022.
Understanding each role’s obligations is the first step toward full compliance.
Apply Good Clinical Practice (GCP) Standards
Sponsors must ensure all trial staff are trained in Good Clinical Practice. Investigators should oversee site staff to verify training is current.
Also, both parties must follow GCP guidelines such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) standard.
By applying these standards, the team protects participants and ensures data integrity.
Secure Regulatory Approvals Before Commencement
A trial cannot begin without regulatory and ethics committee approvals. In Kenya, sponsors submit applications to the PPB and obtain a favourable opinion from an accredited ethics committee.
Investigators must confirm the approvals before enrolling participants. Delays or shortcuts risk non-compliance and possible suspension.
Manage Protocols and Amendments Diligently
Protocols establish how the trial will operate. Sponsors must quickly apply for amendments when new information affects participant safety, data quality or trial conduct.
Investigators must implement approved amendments and maintain documentary evidence of approval and effect. Failing to follow this step may invalidate results or trigger regulatory enforcement.
Monitor Participant Safety and Report Adverse Events
Both sponsors and investigators carry major duties for safety monitoring. Sponsors must report serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) within specified timelines.
Investigators must ensure timely reporting and follow-up information. Maintaining a safety log and documenting causality are essential for compliance.
Data Integrity, Monitoring and Trial Master File (TMF)
Data from the trial must be accurate, complete and reliable. Sponsors should establish monitoring systems and audit trails.
Investigators must keep the Trial Master File (TMF) and essential documents that reflect compliance with GCP. During inspection, regulators will review these files to verify compliance.
Ensure Inspections and Regulatory Interaction Are Handled Correctly
Regulatory authorities can inspect sites or sponsors to ensure compliance with legal and ethical standards. Under Kenya’s rules, the PPB may inspect before or during the trial.
Sponsors should support these inspections, and investigators must grant access to records when requested. Non-compliance may lead to suspension of approval or other penalties.
Close-Out, Reporting and Archiving
When a trial ends, sponsors must notify the PPB and submit a summary report within defined timelines. Investigators must ensure all sites complete their close-out procedures and archive records as required. Proper archiving safeguards compliance and future audits.
Practical Checklist for Sponsors & Investigators
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Confirm ethics and regulatory approvals before recruitment.
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Maintain documented GCP training for all staff.
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Implement protocol amendments through formal processes.
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Establish and maintain safety-reporting workflows.
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Ensure data monitoring, audits, and complete TMF.
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Prepare for regulatory inspections: keep records up to date.
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Archive essential documents according to regulatory requirements.
By using this checklist, teams can stay audit-ready and compliant throughout the trial lifecycle.
Why Compliance Matters for Stakeholders
Participants rely on sponsors and investigators to protect their rights and safety. Regulators expect trials to deliver valid results and maintain trust in medical research. Sponsors and investigators who stay compliant safeguard their reputation, avoid legal consequences and ensure their data is valid for regulatory submission.
How Clarity Pharma Consultancy Can Help
If you are a sponsor or investigator conducting clinical trials in Kenya or regionally, we at Clarity Pharma Consultancy specialise in compliance support, regulatory strategy, documentation review and audit-preparation. We help you build robust systems, train your team and maintain the high standards required for successful, compliant trials.
Compliance in clinical trials is not optional—it’s essential. Sponsors and investigators must continuously uphold ethical, regulatory and operational standards to protect participants, deliver quality data and meet regulatory scrutiny.
By following the clear steps above, you strengthen your trial’s integrity and increase your chance of success.
FAQs
What is the investigator’s primary role?
The investigator oversees the trial at a specific site, ensures the protocol and GCP are followed, and safeguards participant welfare.
What are the key timelines for reporting adverse events in Kenya?
Under Kenyan regulations, sponsors and investigators must report fatal or life-threatening SUSARs immediately (within 7 days) and submit completed reports within 15 days.
Can a protocol be amended after the trial starts?
Yes, but amendments must be approved by the ethics committee and submitted to the PPB before implementation if they affect participant safety, data integrity or trial conduct.
