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Vol. 8, No. 2, February 2012Happy Trials to Outsource Documents for Clinical Trial Visits By Paula Smiles When a pharmaceutical company submits a New Drug Application (NDA) to the Food & Drug Administration
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What is source documents for clinical?
Source documents for clinical trials are original documents, data, and records that are generated or required to record information about a trial subject's participation in the research.
Who is required to file source documents for clinical?
The principal investigator and research team members are typically responsible for filing the source documents for clinical trials.
How to fill out source documents for clinical?
Source documents for clinical trials should be filled out accurately, completely, and legibly, following the protocol requirements and standard operating procedures outlined by the research institution.
What is the purpose of source documents for clinical?
The purpose of source documents for clinical trials is to provide a detailed and transparent record of all information related to the conduct and results of the trial, ensuring data integrity, compliance with regulations, and accountability.
What information must be reported on source documents for clinical?
Source documents for clinical trials must include information such as the subject's informed consent, medical history, study interventions, adverse events, and any other data relevant to the trial protocol.
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