FDA OSI Site Reports

The US FDA OSI may request a series of discrete datasets items be provided to facilitate development of clinical investigator and sponsor/monitor/CRO inspection(s) assignments. Accordingly, we can combine and provide adequate trial related and site related information.

Clinical034The goals of the Office of Scientific Investigations (OSI) are to verify the integrity of efficacy and safety data submitted to the FDA in support of new drug applications (NDAs) and to assure that the rights and welfare of human research subjects are protected.

 

This translates onto the following tasks:

  • Auditing and verifying clinical trial data submitted to the FDA in support of applications to demonstrate the safety and efficacy, or bioequivalence, of drugs for human use;
  • Directing inspections of Institutional Review Boards for compliance with standards and regulations designed to protect the rights and welfare of human research subjects; and
  • Ensuring that investigators, sponsors, and contract research organizations who conduct nonclinical and clinical studies on investigational new drugs comply with United States laws and regulations covering good clinical practice and good laboratory practice.

Request for Subject Level Data Listing by Site (per clinical trial)

We support (would provide, at your convenience) deliverables requested by OSI, such as:
  • Listing for each subject consented/enrolled; for subjects who were not randomized to treatment and/or treated with study therapy, include reason not randomized and/or treated.
  • Subject listing for treatment assignment (randomization).
  • Listing of subjects that discontinued from study treatment and subjects that discontinued from the study completely (i.e. withdrew consent) with date and reason discontinued.
  • Listing of per protocol subjects / non-per protocol subjects and reason not per protocol.
  • By subject listing of eligibility determination (i.e. inclusion and exclusion criteria).
  • By subject listing, of AEs, SAEs, deaths and dates.
  • By subject listing of protocol violations and/or deviations (reported in the NDA, including a description of the deviation/violation).
  • By subject listing of the primary and secondary endpoint efficacy parameters or events. (For derived or calculated endpoints, provide the raw data listings used to generate the derived/calculated endpoints).
  • By subject listing of concomitant medications (as appropriate to the pivotal trial).
  • By subject listing, of testing (e.g. laboratory, EKG) performed for safety monitoring …
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