This Training and Certification program is available only as a member benefit to Student and Associate Members of Clinical Research Society.
The main aim of this training and certification program is to provide the individual with a robust understanding of the clinical research industry, historical perspective of drug development, basic concepts and methodologies in research, ethics in human research, and many other relevant topics. This great program was envisioned with students and future entrants in mind who have pursued any science related degree online or at a college campus. Students who have obtained degrees such as in Pharmacy, Medicine, Dentistry, Biochemistry, Masters in Public Health or Nursing degree are more likely to attend. An ECRP certificate is designed for individuals who have little or no experience with clinical research. Having relevant knowledge in clinical research will make them highly attractive to potential employers.
Benefits of ECRP Training & Certification:
Sponsors, CROs and other agencies involved in the conduct of clinical trials and other types of medical research are increasingly looking for certified individuals who have undergone standardized and validated training and certification so that they can be relied upon to manage the tasks given to them. The performance of a clinical research professional is critical to the success of a project. Companies or organizations that are involved in the conduct of clinical trials must follow regulations and guidelines that define the quality of data generated by clinical research sites, the manner in which this data is collected and handled, and the protection of research subjects, to name a few. The ECRP Training & Certification Program that leads to the award of Emerging Clinical Research Professional (ECRP) helps individuals to demonstrate their commitment towards shaping a career in clinical research and towards professional excellence through a validated certification process. This goes a long way to be a great value addition to their background, education, work experience and demonstrates adequate training in clinical research.
ECRP Training & Certification Program Structure:
The ECRP Certification program is a structured program that delivers core trainings in all basic areas of drug development and clinical research. Following are some of the important areas in which training is provided after signing up for the ECRP certification program.
This study module that comprises of multiple lectures and presentations introduces the individual to the pharmaceutical and clinical research industry. It also provides for a comprehensive assessment of the clinical research industry and the history and milestones that have led to the present clinical research landscape. The introductory module also educates the individual on the stakeholders in clinical research and the Principles of Good Clinical Practice (GCP). Technologies in clinical trial management are discussed in detail, and the individual also is provided comprehensive knowledge on the major clinical research regulatory bodies that exist globally.
– Drug Development:
This module provides training on Pre-clinical development of drugs and biologics and provides an overview of clinical new drug development.
– Ethics in Drug Development:
This module that comprises of multiple lectures explains the concept of ethics in clinical research, Informed Consent Process, Documentation and HIPAA and also provides training in International Conference on Harmonization (ICH).
– Regulations in Clinical Research:
This module provides training in FDA regulations.
– Roles & Responsibilities:
It is critical that responsibilities be defined for all stakeholders in the management of clinical trials, so that expectations that are reasonable can be defined. This module provides comprehensive understanding of the responsibilities of the clinical investigator, sponsors, vendors and Institutional Review Boards (IRB).
– Safety Reporting in Clinical Research:
One of the most important responsibilities of clinical research professionals is to ensure that they are in compliance with their responsibilities for adverse event reporting. To achieve this, they must be knowledgeable about both the regulatory and sponsor-specific requirements for reporting serious and non- serious adverse events in clinical trials. This includes the correct use and completion of the adverse event forms, and definitions and terms of reporting adverse events that may extend beyond the regulatory requirements. This module provides training on documenting and reporting adverse and serious adverse events in clinical trials.
– Careers in Clinical Research:
This module provides an overview of how to shape your career in clinical research. It will provide information about various roles you can assume and various career paths available in the drug and device development enterprise.
CRS has partnered with ProctorU to offer proctored exams for all Certification Programs. To ensure integrity, security & consistency of the examination process, real people oversee proctored exams. Proctored exams are a required component of the certification programs at CRS. You can schedule an examination at your convenience after registering for the exam and paying the examination fee of USD 18/- on the CRS website. Scheduling of examinations with proctorU will not incur any additional cost unless the exam is scheduled within 3 days of the date of scheduling. The ECRP examination will be of 1 hour duration.
ProctorU allows individuals all over the world to take their exams online while ensuring academic integrity for the institution. ProctorU uses a three-step process to replicate the face-to-face proctoring experience over the Internet. Through this process, proctors can see the student, observe their computers, and know whom they are monitoring. ProctorU does this while adhering to the highest accreditation standards in the industry. ProctorU is a pioneer in the industry and serves close to 100 partnership institutions including Northwestern University, the University of Florida and the University of Illinois. You can find more information on ProctorU here.
While the training provided though our ECRP training program is extensive and broad in scope, members are nevertheless tested on their understanding of basic concepts and knowledge based upon other resources that he/she may have been directed to during their training. These resources may include the FDA website, international and/or local policies, regulations, and guidelines, best practices, etc. We provide an exhaustive list of such resources through our Learning & Certification Portal.
The certification exam must be taken within 3 months of registration.
Maintenance of Certification:
The ECRP certification is valid as long as the Student/Associate membership stays active.
How to Apply:
No application is required to apply for ECRP Training & Certification. You need to apply for CRS Student or Associate Membership and upon confirmation of your membership you will automatically be enrolled in the ECRP Training & Certification Program.