Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

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With the world on pandemic lockdown and remote monitoring becoming a necessity, sponsors are increasingly turning to a risk-based approach to make sure they focus their limited time and resources on checking the data most critical to trial success. But risk-based monitoring requires processes not normally covered in monitoring SOPs.

The newest addition to CenterWatch’s library of SOP manuals, Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials, provides you with the information you need to adapt your monitoring plan to changing times.

Implement risk-based monitoring methods into your daily practice and as part of your organization’s training program with this customizable manual. You’ll have the following SOPs, templates and worksheets guiding you along on:

  • Procedure
  • Scope
  • Responsibility
  • Process overview
  • Specific processes
  • Applicable regulations, standards and guidelines
  • References to related SOPs

Alongside supporting documents like templates and worksheets, you’ll also gain insight on key guidelines to

  • Identify FDA recommendations for remote monitoring and communication practices
  • Determine critical types of data and processes:
    • Informed consent
    • Adherence to protocol eligibility requirements
    • Investigational product accountability
    • Adverse event reporting
  • Assess risk in a clinical trial
  • Evaluate factors to consider when developing a monitoring plan
  • Understand the structure and content of risk-based monitoring reports

Customize each SOP by adding your organization’s name and job titles, modify and create your own procedures, or even adapt procedures to suit individual trials, sites and investigators. Order your copy today.

Who Will Benefit

  • Sponsors of clinical trials
  • CROs
  • Academic institutions training clinical trial monitors
  • Clinical trial consulting groups
  • CRAs
  • Clinical operations managers
  • CRA trainers
  • Consultants
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