The CRA Training Institute

The PI conducts the trial with the assistance of CRCs who are often involved in essential duties that have been traditionally performed by the PI, such as conducting the informed consent process and ensuring compliance with the protocol.

The PI’s primary responsibility, as with all clinical research professionals, is the protection of human subjects. Although not inclusive, some of the PI's responsibilities include:

• Document adverse events;
• Prepare or review documents submitted to the institutional review board (IRB);
• Protocol review or study procedures planning;
• Participate in conducting subject visits;
• Maintain source documents;
• Prepare for and participate in study visits with monitor, sponsor, auditors, etc.;
• Participate in consent process;
• Writing the informed consent document;
• Developing a detailed cost analysis;
  
• Negotiating the budget with the Sponsor (i.e. pharmaceutical company or granting agency);
• Subject recruitment;
• Patient care;
• Preparing the case report form (CRF);
  
• Submitting CRFs and other data to the Sponsor/CRA as necessary; and
  
• Study close-out.

Upon completion of the course, participants will be able to:-

• Carry out study activities to ensure compliance with protocols and with all relevant local, federal,
• and state regulatory and institutional polices.
• Maintain required records of study activity including case report forms, drug dispensation records,
• or regulatory forms.
• Code, evaluate, or interpret collected study data.
• Track enrollment status of subjects and document dropout information such as dropout causes and
• subject contact efforts.
• Record adverse event and side effect data and confer with investigators regarding the reporting of
• events to oversight agencies.
• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event
• reports, institutional review board documents, and progress reports.
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Maintain contact with sponsors (CRAs) to schedule and coordinate site visits or to answer questions
• about issues such as incomplete data.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of
• medical records, and discussions with physicians and nurses.
• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.

The PI certificate is recognized internationally in all the countries that are signatories to the ICH-GCP guidelines for clinical trials. This includes USA, Canada, Israel, Germany, Switzerland, Italy, UK, France, EU countries, Russia, Ukraine, Czech Republic, China, Spain, India, Japan, Hong Kong, Australia, New Zealand, Singapore, South Africa and many others.