Types of site visits by CRA

Types of site visits by CRA

A Clinical Research Associate (CRA) can be employed directly by the sponsor companies (such as Pharmaceutical, Biotechnology, or any research company) of clinical trials or by Contract Research Organizations (CROs), also referred to as Clinical Research Organizations. According to ICH GCP, these organizations conduct clinical trials on behalf of the sponsor companies. Let’s learn about the types of clinical trial site visits conducted by CRAs.

The primary responsibility of a CRA is to ensure that the rights, safety, and well-being of subjects participating in clinical trials are protected. The CRA acts as the main mode of communication between sponsors and the site.

A Clinical Research Associate qualifies, initiates, monitors, and closes the clinical trial sites assigned to him/her. Based on their level of experience, CRAs can be hired at various levels such as CRA Level I, II, III, and as Senior CRA by employers.

Some common on-job responsibilities of CRAs include:

  • Conducting visits and monitoring clinical trial sites to ensure adherence to ICH GCP guidelines, study protocol, and applicable regulations.
  • Preparing site visit reports within the stipulated time.
  • Creating, developing, and writing trial protocols for presentation to the steering committee.
  • Identifying suitable facilities to use as clinical trial sites.
  • Setting up trial sites and ensuring each center has the trial materials, including the trial drug, often known as the investigational medicinal product.
  • Archiving study documentation and correspondence.
  • Preparing final reports and SOPs in accordance with ICH GCP guidelines.
  • Ensuring that only qualified, delegated individuals are working as site staff and that they are adequately trained.
  • Ensuring that data collected is accurate, verifiable, and in line with ALCOA.
  • Managing clinical trial site payments and handling ongoing negotiations.
  • Ensuring that the site has acceptable infrastructure and that it remains so throughout the study.
  • Acting as a mentor to site staff, providing continuous support and guidance.
  • Ensuring appropriate filing of study documents, Site Investigator files, and archival.

Required skills for a Clinical Research Associate include:

  • Understanding of the drug development process, knowledge of ICH-GCP, and relevant regulatory guidelines.
  • Strong communication skills.
  • Ability to work under pressure.
  • Multi-tasking ability and willingness to travel.
  • Independence in work.
  • Effective problem-solving skills.
  • Decision-making ability.
  • An eye for detail and verification.

The process of outsourcing and flow in clinical trials involves:

  • Contract signing by CRO, Sponsor, and Investigator.
  • Design and development of the Protocol & Informed Consent.
  • Approval of Protocol, Informed Consent, Source Documents, Letter from IRB, and regulatory.
  • Patient Recruitment, Advertising & Marketing, Participation, Pre-screens, Qualifying, Scheduling, Exams, Monitoring, Follow-up Visits and Calls, Data Entry, Review for Accuracy, Statistical Analysis, Analyzing the Data, Completion of Study Summary, Summary Forwarded to Sponsor, Data Filed and Stored, Study Closure.

I am listing the types of Clinical Trial Site Visits conducted by CRAs, which may vary depending on industry practices:

  1. Site Qualification Visit: This involves confirming whether the hospital infrastructure and setup are qualified/capable of conducting the clinical trials. It is also referred to as a Site Selection Visit (SSV) or Pre-Study Qualification Visit (PSQV). Discussions during this visit include investigator responsibilities, study objectives, IRB requirements, adverse event reporting, infrastructure, and event documentation. This 1-day visit is followed by the preparation of an SQV report by the CRA.
  2. Site Initiation Visit (SIV): Conducted before the start of patient recruitment, this ensures that the Investigator team has the necessary resources to conduct human subject research under an Investigational New Drug Application (IND). It typically takes 2 days and includes training site staff, confirming readiness for study implementation, and identifying additional requirements.
  3. Site Monitoring Visit: This involves overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported according to the protocol, SOPs, GCP, and applicable regulatory requirements. The CRA schedules and conducts these visits, ensuring regulatory documentation and CRFs are completed, and addresses any issues.
  4. Site Close-Out Visit: This ensures that all regulatory documents and data are completed, and any Investigational Products or supplies are returned or destroyed with documentation. The Principal Investigator must be available to sign off on all documents required for closeout.

In conclusion, these are the basic types of Clinical Trial Site Visits conducted by CRAs. I will provide detailed information about each visit in upcoming articles.

Article By: Shahenaz Karadesai

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