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Feasibility and Protocol Selection SOP Considerations

 When creating an SOP on the topic of feasibility and protocol selection, you should keep the following in mind:

  • When a study is offered to the site, the Principal Investigator must review the protocol design and evaluate if it is ethical as per the standard of care in the country and the institution. The Investigators must evaluate as well if the protocol can be implemented in the country, considering the infrastructure needed.
  • In case there is a special need from the site for conducting the trial, the Investigator must add this need at this point in time.
  • It is extremely important to understand how many potential patients the site can screen and randomize in the trial. This data can be inferred as per the potential of patients using different recruitment strategies at the site level.
  • The site must consider if they are currently involved in any trials that would compete for the same patient population. It is recommended not to have trials running at the same time competing for the same pool of patients.
  • The site must consider the regulatory timelines as well at the country level and evaluate if there is enough time to recruit the subjects proposed.
  • The site should organize the workload and make sure the feasibility can be answered on time, and that there is staff available for conducting the trial.
  • The site can add in this procedure specific requirements that the site has to take protocols.