Certification Program for Clinical Trial Investigators© CCP (Certified Clinical Research Physician) Table of Contents Certification Program for Clinical Trial Investigators The Clinical Research Institute of America has developed a certification program that is flexible and accessible to all physicians who are looking into entering the exciting world of clinical research. It is also aimed at clinical research physicians who are seeking to complete their qualifications by obtaining the designation of CCP – Certified Clinical Research Physician.
CCP – The Certified Clinical Research Physician The Certification of the Clinical Research Physician is an acknowledgement to medical professionals that they have achieved the expected professional standards and have fulfilled all the requirements established by the Institute in relation to clinical research. The Certified Clinical Research Physician has demonstrated through training and experience the necessary knowledge and background to perform all activities and assume all responsibilities established by the FDA 21 CFR 312 & 812 and ICH-GCP. The Certified Clinical Research Physician is prepared to run clinical trials with a sound knowledge of clinical research ethics, rights and responsibilities. Certification process The Clinical Research Institute of America has developed a unique certification process. The Institute will prepare the candidate in all established areas. The eligibility criteria is flexible enough to allow access to all qualified physicians interested in becoming principal investigators in clinical trials. We take into account that the Clinical Research Physician is a very busy professional that does not have the luxury of spending time figuring out the regulations and requirements through web based training, books or handouts. For that reason, the candidate participates in three training sessions. After each training session, a detailed exam is taken. Each session prepares the candidate for the next level of comprehensive knowledge. All eligible candidates can go through the process in a time and resource effective manner, and the Institute provides all necessary training and materials to achieve certification. The certification process of the Clinical Research Institute of America involves the successful completion of three levels of training courses. A certificate is issued upon completion of each step. The full *CCP certification is granted to a candidate that successfully completed all 3 steps and also has met additional requirements, specified under the title: “To Complete the CCP Certification Process”. Step 1 Eligibility Criteria To participate in the Step 1 of the certification process, the candidate must be a medical professional (MD, DO, or equivalent), licensed in the state or province of practice, and in good standing with the state/province/regional regulatory, licensing and certifying bodies. No experience in Clinical Research is required at this point.
Process - All candidates must register with the Clinical Research Institute of America and pay a $150 non-refundable fee.
- Upon registration a candidate number is provided together with a schedule of the training courses.
- The candidate enrolls in the training course “Clinical Research for the Principal Investigator- (A005)” and must participate in the 2 full days of training. At the end of the second day, the candidate will take a comprehensive exam.
- Upon satisfactory completion of the exam the candidate will receive the Step 1 certificate that counts towards the CCP* certification. Examination results will be mailed to the candidates. If the candidate did not achieve the minimum expected requirement of 75%, a certificate of attendance will be issued and the candidate will have the opportunity to take the exam, on the next scheduled date (an exam fee applies).
Step 2 Eligibility Criteria To participate in the Step 2 of the certification process, the candidate must pass Step 1 and remain licensed in the state or province of practice, and in good standing with the state/province/regional regulatory, licensing and certifying bodies. Although, no experience in Clinical Research is required, the candidate is encouraged to start participating actively in clinical research activities.
Process - Upon completion of Step 1, the candidate is prepared to attend the training session “Clinical Trial Data Management and Resolution – (DMR01)”. This is a 2 day workshop where the candidate will walk through the process of data capture, transfer and verification as well as resolution and regulatory compliance. Source documentation and electronic systems as well as 21 CFR 11 and its impact in clinical research, will be discussed.
- The candidate must participate in the 2 full days of the above mentioned workshop and at the end of the second day, the candidate will take a comprehension exam.
- Upon satisfactory completion of the exam the candidate will receive the Step 2 certificate that counts towards the CCP certification. Examination results will be mailed to the candidate. If the candidate did not achieve the minimum expected requirement of 75%, a certificate of attendance will be issued and the candidate will have the opportunity to take the exam on the next scheduled date (an exam fee applies).
- At this point the candidates are strongly encouraged to participate in clinical research.
Step 3 Eligibility Criteria To participate in the Step 3 of the certification process, the candidate must pass Level 2 and remain licensed in the state or province of practice, and in good standing with the state/province/regional regulatory, licensing and certifying bodies. Process - Upon completion of Step 2, the candidate is eligible to choose to attend one or both of the following training sessions :
- The Patient Information and Consent Process – (PIC01):
This is a two day intensive program that will present the issues of obtaining a fully ethical and compliant consent. This practical course involves staged clinical research volunteers posing as patients in order to recreate the potential scenarios of consent. This is a 2 day learning experience that will allow investigators to understand and be able to apply the knowledge acquired. - GCP (Good Clinical Practices) /GLP (Good Laboratory Practices) an intersection in Clinical Research- (GCLP01):
This is a two day intensive program that will present the issues on clinical trials that are unconventional but, by every day, more common. This program will prepare the principal investigator to also assume the role of the sponsor, and to understand the essentials of running clinical trials with FDA regulated products. - The candidate must participate in the 2 full day session(s) of the chosen course(s) and at the end of the second day, the candidates will take a comprehensive exam.
- Upon satisfactory completion of the exam the candidate will receive the Step 3 certificate that counts towards the CCP certification. Examination results will be mailed to the candidates. If the candidate did not achieve the minimum expected requirement of 75%, a certificate of attendance will be issued and the candidate will have the opportunity to participate to the exam in the next scheduled date (an exam fee applies).
To Complete the CCP Certification Process To complete CCP certification, the candidate must have successfully completed all three specified steps. Also, the candidate should have at least 1 year of combined experience as a clinical research principal investigator, coordinator, monitor, or in another related function. The experience should be documented in the form of a letter issued by a sponsor /institution where the candidate participates as a clinical research member. The letter should include the IND number and a Clinical Trial Registration number issued by ClinicalTrials.gov Protocol Registration System.
Certification process schematic diagram 
Maintenance of the CCP Certification Every year the Certified Clinical Research Physician (CCP) is required to complete a refresher program with the Institute that is designed to bring physicians up to date on new regulatory and practical issues in clinical research. The refresher courses can be found on www.criamerica.com. An on-line maintenance program is also being developed to allow flexibility. Also, in the future, the maintenance program will accept contact hours provided by other continuing medical education institutions, as they become available.
Applicable Fees The candidate to the Certification Program will incur in the following fees:
| Item | Fee (U$D) | | Registration | 150.00 (non refundable) | | Course Step 1 | 1,250.00* | | Course Step2 | 1,250.00* | | Course Step3 | 1,250.00* | | Optional course Step 3 | 1,250.00* | | | | | Certification Maintenance Course | 650.00** | | Exam retest fee | 150.00 | | Certificate reissue (copy) | 100.00 | | Original Certificates | No charge |
*Early-registration may allow the participant to save up to 30% of the original cost
**Certification maintenance courses are 1 day refresher programs, although the CCP holder may also take any other related course offered by the Institute, at the corresponding fee.
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