Standard Operating Procedure for Planning and Approving Clinical Study Protocols
Purpose
The purpose of this SOP is to outline the process for developing and obtaining approval for study protocols in clinical research. This SOP aims to ensure that protocols are scientifically sound, ethically compliant, and adhere to regulatory standards.
Scope
This SOP applies to all personnel involved in the development, review, and approval of study protocols in clinical trials. This includes principal investigators, clinical researchers, ethics committees, and regulatory bodies.
Responsibilities
- Principal Investigator (PI): Leads the development of the study protocol and ensures its scientific rigor and ethical integrity.
- Study Team: Assists the PI in drafting and refining the study protocol.
- Ethics Committee: Reviews and approves the protocol to ensure ethical compliance.
- Regulatory Affairs: Ensures the protocol meets regulatory requirements and submits it for regulatory approval.
Procedure
- Protocol Drafting:
- Develop the study protocol according to scientific and ethical guidelines.
- Include study objectives, design, methodology, and safety measures.
- Incorporate inclusion and exclusion criteria for participant selection.
- Detail the data collection and analysis plan.
- Internal Review:
- Conduct an internal review of the protocol with the study team and other stakeholders.
- Address any feedback or concerns raised during the review.
- Ethics Committee Submission:
- Submit the protocol to the ethics committee for review and approval.
- Provide all necessary supporting documents (e.g., informed consent forms, participant
information sheets).
Regulatory Submission:
Protocol Finalization:
- Submit the protocol to regulatory authorities for review and approval if required.
- Address any queries or requests for changes from regulatory authorities.
- Make any necessary revisions based on feedback from the ethics committee and regulatory authorities.
- Finalize the protocol and obtain all necessary approvals.
Abbreviations Used
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- IRB: Institutional Review Board
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
Documents
- Draft and final versions of the study protocol
- Informed consent forms
- Participant information sheets
- Ethics committee and regulatory approval letters
- Correspondence with ethics committee and regulatory authorities
References
- Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
- Institutional policies and procedures
- Ethics committee regulations
SOP Version
Version: 1.0
