Designing scientifically sound protocol in Clinical Trial
Protocol is a pivotal document for
conducting a clinical trial. All the different steps that would be implemented
and executed in a clinical trial have to be clearly documented in protocol.
Generally the sponsor of a clinical trial would draft the protocol. Once a protocol is drafted
initially it undergoes different corrections and modifications before deciding the
final version. But drafting and finalizing a clinical study protocol is not
sufficient to start a clinical trial.
Before
starting a clinical trial the protocol along with other important documents
like Informed consent form (ICF), case report form (CRF) has to be sent to the regulatory
authorities for approval. The regulatory authorities in different countries
would check the proposed protocol thoroughly with special emphasis on the
safety, well being of the subjects. If the design of the study in the protocol
and well as the methodologies that is depicted in protocol, reflects that trail
subjects safety is maintained, then the protocol gets approved. Designing a
scientifically strong protocol is one of the most important step in any clinical
trial.
Nice information
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Clinical Trial Services
Scientific Medical Writing
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Regulatory Affairs writing Services.
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