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The scope of an SMO's responsibility is limited to the site and hence the eponymous title. Some (but not all) of the responsibilities include: Contract; Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval. In Europe, submission to Ethics Committee is often done by sponsor or by CRO, i.e. not by SMO
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient's participation in the clinical trial.
GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.
It further details the sponsor's responsibilities in its good clinical practice guidelines: [8]: 22–23 (5.2.1) A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.
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An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [ 1 ]
A data clarification form (DCF) [1] or data query form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or contract research organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data ...
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