Accreditations and Memberships
ACCRE - Clinical Research Professionals
CCRPS CRA Certification and CRC Certification is accredited by The Accreditation Council for Clinical Research Education (ACCRE) in June 2019 Code: 463-03-005-GPC08
ACCRE accredits the professional program in Clinical Research leading to the Certificate of Clinical Research. Evaluation and accreditation of this program is in accord with standards and guidelines for the professional program in Clinical Research leading to the Certificate of Clinical Research, adopted June 14, 1997 and effective July 1, 2000. Clinical Research education is in the process of transition as reflected by a corresponding change in accreditation standards.
The ACCRE is recognized for the accreditation and pre-accreditation of professional programs in Clinical Research by the biotechnology and pharmaceutical industries. ACCRE accreditation serves to establish eligibility for participation in a variety of biopharmaceutical industry funded programs, not including eligibility for Title IV Programs, Higher Education Act, 1965, as amended.
For the public, accreditation assures conformity to general expectations of the profession and identification of colleges and schools of Clinical Research which have explicitly undertaken activities directed at improving the quality of their professional programs, and are carrying them out successfully. Accreditation also assures improvement in the professional services available to the general public in that accredited programs are expected to modify their requirements to reflect advances in knowledge and practice.
For students and prospective students, accreditation provides an assurance that a program has been found to provide satisfactory educational preparation for practice in the field
For institutions of higher education, accreditation provides a framework for self-evaluation and improvement as well as opportunity for external review and counsel. Accreditation also provides a basis for the decision-making of private and public agencies in the awarding of grants, scholarships and loans.
For the profession, accreditation provides a means for practitioner participation in the setting of requirements for preparation to enter the profession.
MSA-CSS - Candidate for Accredited Career Institution
CCRPS is a candidate undergoing a 1 year intensive study for approval to be a federally recognized career and technical institution. MSA-CSS accredited postsecondary, non-degree granting career and technical institutions may use their Middle States accreditation to establish eligibility to participate in federal Title IV student loan programs for adult students (FAFSA, federal student funding). The Commission on Secondary Schools is now recognized by the U.S. Department of Education as a gatekeeper for eligibility for Title IV funding for postsecondary, non-degree granting institutions and distance education throughout the United States.
ICE Organizational Membership
An association, certifying organization, consumer group, or government agency
Joint Accreditation - Physicians, Nurses, Pharmacists, Healthcare Providers
Advanced Clinical Research Professionals
Jointly provided by Postgraduate Institute for Medicine and Certified Clinical
Research Professionals Society (CCRPS)
Release date: July 14, 2020
Expiration date: September 8, 2025
Estimated time to complete activity: 17.5 hours
Target Audience
This activity is intended for physicians, nurses, pharmacists, and professionals engaged in
care of patients in clinical trials.
Educational Objectives
After completing this activity, the participant should be better able to:
Describe the ICH GCP protocol including FDA 21 CFR, E2A, 5,5 E6, and Ethics
Explain the Quality Monitoring process including designing trials, site visits, monitoring visits, close out visits, protocols, and reporting violations.
Outline the process and professional roles involved in audit and inspections.
Appropriately detect and report misconduct and fraud.
Apply concepts of clinical research roles in a multiple choice examination.
Faculty
Dr.Kamaljit Tiwana, Diedre Clarke, Sahar Khan
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
Faculty have nothing to disclose.
The PIM planners and others have nothing to disclose. The CCRPS planners and others have nothing to disclose.
Method of Participation and Request for Credit
In order to obtain your CME/CE certificate, please follow the steps below at the conclusion of the activity:
Go to www.cmeuniversity.com
Login or Create a New Account (will take less than 1 minute)
If you receive a message when creating a new account that “the email you entered is already in use”, please click the Forgot my Username or Password link to have your Username and Password sent to you via email
After logging in, you may be asked to verify/update your information; after doing so, click Save at the bottom of the page
Type in 15592 at the top of the page, “Find Post-Test/Evaluation by Course”, and click enter
Click on the activity title when it appears
Choose the type of credit you desire
Complete the online assessment
Receive an immediate CME/CE Certificate to download and/or print for your files
For Pharmacists: Upon completion of the online evaluation, your credit will be submitted to CPE Monitor. Pharmacists have up to thirty (30) days to complete the evaluation and claim credit. Please check your NABP account within thirty (30) days to make sure the credit has posted.
If you have questions regarding the certification of this activity, please contact PIM via email at inquiries@pimed.com.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Certified Clinical Research Professionals Society (CCRPS). Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Credit Designation
Physician Continuing Medical Education
The Postgraduate Institute for Medicine designates this enduring material for a maximum of 17.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 17.5 contact hours.
Continuing Pharmacy Education
Postgraduate Institute for Medicine designates this continuing education activity for 17.5 contact hour(s) (1.75 CEUs) of the Accreditation Council for Pharmacy Education.
(Universal Activity Number - JA4008162-9999-23-300-H99-P)
Type of Activity: Application
Policy on Privacy and Confidentiality
Please see final activity for the policy on privacy and confidentiality that relates to this internet activity.
Computer System Requirements
The most recent version of one of the following browsers: Chrome, Firefox, Safari, Microsoft Edge
Javascript enabled
PDF plugin
Graphic and audio output capability
Broadband internet connection with a minimum speed of 5Mbps (recommended)
TLS 1.2 supported by your web browser
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.
TransCelerate BioPharma - ICH GCP
Recognizes CCRPS Certification as Evidence of GCP Training. CRA, CRC, and ACRP-F certification available by CCRPS meet the criteria for GCP training. We are recognised by the 20 major TransCelerate associated BioPharma companies through mutual-recognition to prevent overlap in GCP training. Criteria consisted with GCP training include:
(1.24) Definition of ICH GCP
(1.34) Definition of Investigator
(1.56) Definition of Subinvestigator
(1.53) Definition of Sponsor
The Principles of ICH GCP
13 ICH GCP Principles
(4.1) Investigator Qualifications and Agreements
(4.2) Adequate Resources
(4.3) Medical Care of Trial Subjects
(4.4) Communication with IRB/IEC
(4.5) Compliance with Protocol
(4.6) Investigational Products
(4.7) Randomization Procedures and Unblinding
(4.8) Informed Consent of Trial Subjects
(4.9) Records and Reports
(4.10/4.13) Progress Reporting/ Final Reports
(4.11) Safety Reporting
(4.12) Premature Termination or Suspension of Trial(4.10/4.13) Progress Reporting/ Final Reports
(4.11) Safety Reporting
(4.12) Premature Termination or Suspension of Trial