Medical Writing

Essential Trial Documents

Protocol

Describes the objective(s), design, methodology, statistical considerations, and organization of a trial.

Ethics

Trials should be conducted in compliance with the protocol that has received favorable prior institutional review board (IRB)/independent ethics committee (IEC) approval.

Research and Development

Clinical research is not the same as medical practice. A clinical trial is expected to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product, and/or identify any adverse reactions to an investigational product.

Regulatory

Regulatory bodies that oversee clinical trials may include the FDA, EMEA, SFDA.

Research Team

The clinical research team is responsible for delivery of care to study participants.

Participant Information

Documented by means of a written, signed, and dated informed consent form. Certain health information may be protected.

Data collection

Data may be captured on paper but preferably electronically.

Safety

The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

Pharmacy product related

Records of pharmaceutical preparation, dispensation and destruction are maintained throughout the study.

Monitoring and Audit

Systematic and independent examination of trial-related activities and documents.

Correspondence

Copies of all correspondence should be maintained.