CT documentation development

Clinical Trial Documentation Development.

What is Clinical Trial Documentation?

Clinical Trial Documentation refers to the various documents required to design, allow, execute and assess a Clinical Trial.

Throughout the clinical stages of a medicinal product, these and other documents need to tell a consistent story based on the trial data to be successful and progress to Marketing Authorization, requiring extensive trial experience, expertise and planning.

Typically, the essential documents involved are:

  • Investigator’s Brochure (IB) – pre-clinical and clinical information.
  • Clinical Study Protocol – instructions, objectives and guidelines for all.
  • Subject Information and Informed Consent Form – ensures subjects understand the relevant aspects of the study before voluntary confirmation of participation by a subject.
  • Clinical Study Reports – interim and final reports during and on completion of the trial.
  • Case Record Form (CRF) – records all the various data related to an individual trial subject, including patient trial ID, demographic information, prior health and treatment, inclusion/exclusion criteria, dosage, adverse effects, examinations and conclusion.

Why you should choose Arriello to review your Clinical Trial Documentation.

Our experts understand the criticality of having a thorough protocol prior to study initiation, and we can advise you on the best approach to set-up the safety sections during protocol writing.

In addition to your protocol, our clinical safety consultants can provide a full review of your Reference Safety information, clinical/final study reports, and other documents.

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