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Trial initiation

Site initiation visit and training

Be prepared for your trial with a thorough site initiation.

The site initiation visit involves the research team and sponsor representatives reviewing key documents and procedures. This review ensures everyone understands participant eligibility criteria, study procedures, data collection methods, and safety reporting requirements. However, it may not be necessary for all trials.

The research team then undertakes specific training to prepare for the trial. The team is trained in relevant study procedures, informed about the potential risks and benefits of the trial, and taught the relevant legal and ethical guidelines. This step helps to protect participants and ensures the team is fully qualified to increase credibility.

Here’s how you’ll carry out your site initiation visit and training:

  • schedule the initiation visit
  • ensure all documentation is ready and available
  • conduct document reviews
  • train research team – informed consent process, study procedures, data collection methods, and regulatory requirements
  • address any questions or concerns
  • verify training qualifications.

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