Example SOPs: Clinical Research Associate

Clinical Research Associate SOPs

Creating Standard Operating Procedures for your Clinical Research Associate work can be difficult and take time. That’s why we’ve created these example Clinical Research Associate SOPs so you can jumpstart your SOP creation process. We want to help you set up your Healthcare systems and processes by taking these sample SOPs and building out your own SOPs template library. By having all your Healthcare procedures in one place, your team will have the information they need at all times. Let’s look at some Clinical Research Associate SOP examples.

Clinical Research Associate SOP Examples

1. SOP: Study Protocol Review
Purpose: The purpose of this SOP is to ensure that the clinical research associate (CRA) thoroughly reviews the study protocol before initiating any activities. This helps to ensure that the CRA understands the study objectives, inclusion/exclusion criteria, study procedures, and any specific requirements.
Scope: This SOP applies to all clinical trials conducted within the organization.
Person Responsible: The CRA is responsible for reviewing the study protocol.
References: This SOP may reference other SOPs related to study initiation, such as the Investigator Site File (ISF) setup SOP.

2. SOP: Site Selection and Qualification
Purpose: The purpose of this SOP is to outline the process for selecting and qualifying clinical trial sites. It ensures that sites meet the necessary criteria, such as having appropriate infrastructure, qualified staff, and the ability to recruit and retain study participants.
Scope: This SOP applies to the CRA responsible for site selection and qualification.
Person Responsible: The CRA is responsible for conducting site selection and qualification activities.
References: This SOP may reference other SOPs related to site initiation, such as the Site Initiation Visit (SIV) SOP.

3. SOP: Site Initiation Visit (SIV)
Purpose: The purpose of this SOP is to provide guidance on conducting site initiation visits. It ensures that the CRA effectively communicates study requirements, provides necessary training to site staff, and verifies that the site is ready to initiate the study.
Scope: This SOP applies to the CRA responsible for conducting site initiation visits.
Person Responsible: The CRA is responsible for conducting site initiation visits.
References: This SOP may reference other SOPs related to study initiation, such as the Investigational Product (IP) handling SOP.

4. SOP: Source Document Verification
Purpose: The purpose of this SOP is to outline the process for verifying source documents against data entered into the electronic data capture system. It ensures data accuracy and integrity by comparing source documents, such as medical records and laboratory reports, with the data collected during the study.
Scope: This SOP applies to the CRA responsible for source document verification.
Person Responsible: The CRA is responsible for conducting source document verification.
References: This SOP may reference other SOPs related to data management, such as the Data Entry and Query Resolution SOP.

5. SOP: Adverse Event Reporting
Purpose: The purpose of this SOP is to establish a standardized process for reporting adverse events (AEs) occurring during the clinical trial. It ensures timely and accurate reporting of AEs to the appropriate regulatory authorities, ethics committees, and study sponsors.
Scope: This SOP applies to the CRA responsible for adverse event reporting.
Person Responsible: The CRA is responsible for reporting adverse events.
References: This SOP may reference other SOPs related to safety reporting, such as the Serious Adverse Event (SAE) Reporting SOP.

6. SOP: Monitoring Visit Report
Purpose: The purpose of this SOP is to guide the CRA in documenting the findings and observations during monitoring visits. It ensures that all relevant information, including protocol deviations, data discrepancies, and site performance, is accurately recorded and communicated to the study team.
Scope: This SOP applies to the CRA responsible for monitoring visits.
Person Responsible: The CRA is responsible for preparing monitoring visit reports.
References: This SOP may reference other SOPs related to monitoring activities, such as the Source Data Verification (SDV) SOP.

7. SOP: Study Closeout
Purpose: The purpose of this SOP is to outline the procedures for closing a clinical trial. It ensures that all necessary documentation, including study files, regulatory submissions, and final reports, are completed and archived appropriately.
Scope: This SOP applies to the CRA responsible for study closeout activities.
Person Responsible: The CRA is responsible for coordinating study closeout activities.
References: This SOP may reference other SOPs related to study closure, such as the Archiving and Retention SOP.

Note: The specific SOPs may vary depending on the organization and regulatory requirements. It is important for the clinical research associate to adhere to the organization’s SOPs and stay updated with any changes or updates

Clinical Research Associate SOP Templates

Looking for SOP templates for your Clinical Research Associate work? We’ve got you covered. You can build out your company SOPs using the sample SOP information above (added to our template) or our team can put together a starter SOPs template based on your Clinical Research Associate work. Get in touch if you’ve got questions about the quickest way to build out your Healthcare SOPs library.