Sunday, April 4, 2010

Annual Safety Report - Table of Ongoing Clinical Trials

Annual safety reports all include a table of past, present, ongoing, completed and proposed clinical trials as per FDA requirement and rigor. In some instances, a 6 month safety report is requested and required by FDA. For the 6 month safety report, a table of ongoing clinical trials will suffice. The table will include information for all ongoing clinical trials at the time of the safety report submission and will include information pertaining to each ongoing clinical study:
  • study number
  • study subjects treated
  • study design
  • study status
  • study dosing
  • study type
  • number of clinical study investigative sites
  • date of first subject screened
  • date of first subject randomized
  • date of first subject enrolled
  • date of last subject enrolled
  • date of last subject completed.

A safety "cut-off" date is agreed to between pharma and FDA for the reporting period for the 6 month safety report. Remember to review previously submitted safety materials, submissions, narratives, reports and otherwise to ensure accuracy and consistency of data and documentation and reporting - current, ongoing vs. all previously submitted. Remember, safety of the patient or subject on clinical trial is the primary objective of FDA and supersedes the evaluation of effectiveness and efficacy objectives at all times during, pre-, post-submission...all approvals.

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