ICH-CRC-Guide by ramchandavolu

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									ICH CRC Certification Guide – September 2009
ICH CRC CERTIFICATION GUIDE ........................................................................... 1  GENERAL INFORMATION .......................................................................................... 2  BENEFITS OF CERTIFICATION ........................................................................................... 2 INDUSTRY RECOGNITION………………………………………………………… 2 ABOUT THE EXAM ........................................................................................................ 2  CRC DEFINITION ............................................................................................................. 2  REQUIREMENTS FOR ADMISSION TO THE CRC EXAM ...................................................... 3  LANGUAGE ...................................................................................................................... 4  CRC EXAM CONTENT ...................................................................................................... 4  CRC EXAM PREPARATION ............................................................................................... 9  CRC SAMPLE EXAM QUESTIONS ................................................................................... 10  CONTACT INFORMATION ........................................................................................ 10  NON-DISCRIMINATION POLICY ............................................................................ 11  DISCIPLINE & COMPLAINTS POLICY..................................................................11

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General Information
Benefits of Certification
A survey of 357 experienced CCRCs cited personal satisfaction, increased knowledge, and professional recognition as the primary reasons for achieving certification. In addition: Certification is increasingly recognized by today's global clinical research industry. Study sites use certification for documentation to sponsors and CROs that the site is professionally managed. The largest investigator online databases include a request for the study coordinator's certificate number. Certification assists the public, healthcare professionals, and the industry itself by identifying standards for professional practice.

Industry Recognition
Based on a survey of CRCs, those surveyed believed that enhanced professional standing, increased company marketability (for CROs), personal satisfaction, and enhanced recognition by peers and supervisors were the primary anticipated advantages for becoming certified.

About the Exam
The Academy offers the Clinical Research Coordinator Certification Examination (CRC) to qualified individuals. Accreditation as a CRC signifies that a clinical research professional possesses knowledge about the conduct of clinical trials. Certification assists the public, other health care professionals and the industry by identifying standards for professional practice.

CRC Definition
A CRC, regardless of job title, works at a clinical research site under the immediate direction of a principal investigator, whose research activities are conducted under Good Clinical Practice (GCP) and ICH Guidelines. CRCs and other professionals referred to as research nurses, trial nurses, site coordinators, etc., perform tasks such as: Verifying study feasibility Facilitating formal approval Planning trial execution Assisting in subject recruitment Coordinating study procedures Collecting accurate and verifiable data Safeguarding GCP, protocol and investigational product compliance 2

Communicating with the sponsor and regulatory authorities (including audits & inspections) Coordinating study close out To qualify to take the CRC Exam, a candidate must, at a minimum, coordinate study procedures, collect data and communicate with the sponsor and regulatory authorities. The CRC Exam is a measure of the candidate's general skills and knowledge of the information needed for CRCs to perform effectively. Certification is granted in recognition of the candidate's documented education and working experience as a CRC, and successful completion of this written exam. By granting the title of Certified Clinical Research Coordinator (CRC), The Academy is formally recognising the professional CRC who has provided evidence that he or she meets those professional standards.

Requirements for Admission to the CRC Exam
To be eligible to take the CRC exam, each candidate must fulfill by the date of the exam, one of the following two combinations of education and working experience as a CRC. For the purpose of meeting the working experience requirement, a minimum of 2 years full time or 4 years part time must be completed prior to the exam date. A detailed résumé or C.V. and a job description is required and must be included with the exam application. This must include a description of the candidate's roles as a CRC and specific employment dates. The C.V. that is provided by the sponsor is not sufficient because it does not show job function performance. Do not include a list of study participation on your C.V. (See chart for educational requirements.) Requirements Effective Through December 31, 2009: Option 1 Education University degree or Paramedical Qualification (e.g. nurse, pharmacy assistant, medical documentation specialist, etc.) 2 Other education Working Experience as a CRC 2 years full-time or 4 years part-time

4 years full-time or 8 years part-time

Requirements Effective January 1, 2010: Option 1 Education Associate/Bachelor's degree or RN Working Experience as a CRC 2 years full-time or 4 years part-time

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High School diploma (or equivalent) and completion of trade school (e.g. LPM, LVN, Medical Assistant, Lab Technician)

3 years full-time or 6 years part-time

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Completion of an educational 1 year full-time or program in Clinical Research from an accredited institution of 2 years part-time one year’s length

(NOTE: A minimum of 40 hours per week qualifies as full-time employment, and a minimum of 20 hours per week qualifies as part-time employment.)

Those candidates who meet eligibility requirements and pass the exam will be certified as having met The Academy standards for becoming a CRC, as adopted by The Academy. Such certification, however, is neither an endorsement of a particular individual, nor a validation of that person's qualifications for a particular task, and should not be represented as such to third parties. Employers must be listed on the candidate's application form. The Academy has the right to verify qualifications. A detailed résumé or C.V. must also be included with the application. This must include a description of your roles as a CRC and specific employment dates. The C.V. that is provided to the sponsor is not sufficient because it does not show job function performance.

Language
The CRC Certification Exam in ICH regions is provided in the English language. Please note: Exam candidates in ICH regions may bring an English-German / Spanish / Dutch / Italian / etc. dictionary to the exam. The dictionary will be inspected by the proctor prior to and after the exam is completed. Any attempt to compromise the exam will be grounds for immediate dismissal from the centre, invalidation of the exam score, and possible legal action

CRC Exam Content
The Academy's CRC Certification Exam Committee develops the CRC Exam in ICH regions. The Committee regularly evaluates and improves the existing exam questions, and adds new questions to expand the ICH region pool of items. The exam consists of 125 multiple-choice questions. For each question, candidates are asked to choose the single best answer from the options provided. Questions test recall, application, and analysis. Some questions use hypothetical scenarios. The exam content is based on a process of expert peer review, performed by the ICH CRC Certification Exam Committee. The content outline of the CRC Exam and the relative distribution of questions are as follows: 4

Content Outline of the CRC Exam I. Study Management (15 questions) A. Protocol Evaluation 1. Assess and identify the protocol and study design a. phase (i.e., I - IV, pre and post marketing) the protocol is intended to satisfy b. type of study design (e.g., double-blind, crossover) c. compassionate use d. emergency use 2. Follow regulations regarding drugs, biologics, and medical devices 3. Assess protocol for clarity, thoroughness, logistical feasibility, maintaining subject safety and welfare, inconsistencies, etc. 4. Determine subject population availability 5. Determine personnel required to complete the clinical trial (e.g., number needed, availability) 6. Determine facility and equipment availability 7. Develop time lines for conducting and completing the clinical trial 8. Identify concerns and questions with the Principal Investigator and Sponsor/CRO (e.g., patient population, Sponsor/CRO expectations, enrollment, study procedures) 9. Negotiate alternatives to improve protocol implementation (e.g., inclusion/exclusion criteria, concomitant medications, protocol timelines, logistics) 10. Review protocol with sponsor/CRO during Investigator's meeting B. Site Preparation and Initiation 11. Schedule and coordinate pre-study site visit with Sponsor/CRO's representative 12. Prepare regulatory documents for Sponsor/CRO (e.g., investigator agreement, financial disclosure, curriculum vitae, IRB/IEC membership, lab-related documents, delegation of authority, site signature log) 13. Prepare recruitment plan 14. Prepare and submit IRB/IEC documents a. informed consent/children's assent form b. advertisements (e.g., ensure advertisements meets IRB/IEC regulations) c. protocol and protocol summary d. investigator's Brochure e. exempt, expedited, or full committee review 15. Prepare space for study-related equipment and supplies (i.e., storage of study investigational products, laboratory supplies, CRFs/eCRFs) 16. Provide instruction to study team for specific study assignments 17. Present clinical trial time lines to study team (e.g., enrollment, completion, advertising, schedules)

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18. Train/educate ancillary staff regarding clinical trial (e.g., pharmacist, medical secretary, medical technician) 19. Integrate proposed clinical trial with current research activity 20. Coordinate study initiation among clinical staff, subjects, and Sponsor/CRO II. Project Activities (45 questions) A. Investigational Product Accountability 1. Receive investigational product from Sponsor/CRO and inventory supplies 2. Store investigational product supplies according to ICH guidelines 3. Prepare/Dispense investigational product according to the protocol (authorized staff only) 4. Retrieve investigational product and calculate subject compliance 5. Order supplemental investigational product 6. Return used and unused investigational product to Sponsor/CRO 7. Maintain randomization and emergency codes of investigational product dispensing 8. Document on accountability log and subject record (e.g., investigational product received, used, disposed) B. Laboratory and Diagnostic Issues 9. Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration) 10. Develop procedure and collection forms for laboratory/diagnostic collection and storage 11. Communicate laboratory/diagnostic results with Principal Investigator, and Sponsor/CRO 12. Maintain regulatory standards for handling dangerous goods 13. Maintain supply inventory 14. Maintain equipment (e.g., calibration and preventive maintenance) 15. Ensure proper documentation of equipment maintenance (i.e., logs) 16. Recognize common laboratory values and alerts 17. Assure current certification/licensure and normal ranges C. Safety/Adverse Events 18. Assist the Investigator in determining causality of expected or unexpected results associated with investigational products 19. Document adverse medical events 20. Implement Investigator's plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject) 21. Maintain follow-up to determine resolution of adverse event 22. Report SAE to Sponsor/CRO and Serious Unexpected Associated events to IRB/IEC 23. Assist Investigator in classifying severity of adverse events (i.e., serious, severe, moderate, mild, expected, unexpected 24. Record adverse event and relevant information on source document, CRF, and Sponsor/CRO specific form D. Responsibilities and Obligations 6

25. Assist the Investigator in the conduct of research in accordance with the statement of Investigator 26. Maintain the continuity of the clinical trial while satisfying obligations to the Sponsor/CRO 27. Ensure site is prepared for any Regulatory/Sponsor/CRO audits (e.g., consequences, requirements, deficiencies) 28. Maintain current knowledge of clinical research issues (e.g., ICH/GCP guidelines) 29. Implement subject privacy regulations 30. Manage research site staff 31. Prepare for monitoring visit E. Close-Out 32. Determine disposition of study-related materials per Sponsor/CRO requirements 33. Reconcile investigational product accountability 34. Audit documents and pertinent files and prepare for storage 35. Maintain documents as required by ICH guidelines 36. Prepare/obtain study summary and/or close-out letter for IRB/IEC/Sponsor/CRO 37. Provide or verify method of document retrieval from storage 38. Document reasons for subject discontinuation (i.e., causes, contact efforts) 39. Prepare for and respond to internal and Sponsor/CRO audits, and/or regulatory inspections III. Subject Coordination (45 questions) A. Recruitment Implementation 1. Prescreen telephone calls for eligibility requirements 2. Review sources for potential subjects consistent with regulatory requirements (e.g., medical records and databases) 3. Monitor enrollment goals and modify recruitment strategies as necessary B. Informed Consent/Assent 4. Ensure the protection of human subjects (e.g., Declaration of Helsinki) 5. Explain study to subject (e.g., purpose, duration, risks/benefits) 6. Assess subject understanding of study requirements 7. Obtain required signatures 8. Provide subject/legal guardian a copy of informed consent form 9. Document obtaining informed consent in source document 10. Obtain informed consent from vulnerable subject populations C. Scheduling/Screening 11. Screen potential subjects (e.g., to obtain medical history, medications/medical/surgical history) 12. Schedule Subjects a. determine length and timing of visits

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b. coordinate subject visits with support services (e.g., subject, physician, ancillary staff, coordinator) c. determine payor responsibility for designated study visit 13. Send reminders for scheduled visits to subjects D. Study Conduct 14. Perform subject interview and assessments at study visits 15. Monitor study team compliance with protocol, GCP, SOPs and regulations 16. Assure subject safety during trial participation 17. Coordinate/perform study-related procedures (e.g., phlebotomy, vital signs, ECG) IV. Documentation and Administration (20 questions) A. Case Report Forms 1. Review inclusion/exclusion criteria a. make required calculations (e.g., convert units of measurements) b. document concomitant medications c. document medical history 2. Enter data for specific visit on CRF 3. Enter data using electronic data capture systems (e.g., eCRF, PDAs) 4. Verify study data for accuracy 5. Transmit data (e.g., fax, express mail, EDC) as required by Sponsor/CRO 6. Complete and return Sponsor/CRO queries B. Source Documentation 7. Develop checklist for source documentation of study events 8. Incorporate applicable historical documents (e.g., surgical reports, pathology reports, medical history) 9. Obtain and record ancillary services reports (e.g., x-ray, pathology, ECG, laboratory) 10. Maintain progress notes 11. Update subject screening/enrollment log 12. Document written, electronic, and verbal communication with study contacts (e.g., subject, Sponsor/CRO, IRB/IEC, laboratory) 13. Document protocol deviations/violations 14. Maintain communication with IRB/IEC regarding a. continuing review b. serious adverse events c. safety reports d. protocol amendments e. protocol deviations/violations f. informed consent modifications g. final report C. Financial/Budgetary Issues

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15. Assist in the preparation of the budget for study-related costs and associated services 16. Reconcile outstanding financial consideration for study-related services and payments 125 Total Questions

CRC Exam Preparation
To prepare for the CRC Exam, candidates should review and be familiar with the names of commonly ordered blood tests which measure kidney function, liver function, glucose metabolism, and blood counts (i.e. CBC). Normal ranges, if needed, will be provided. Candidates should also be familiar with the following documents: ICH Guidelines (E2, E6, E8) Declaration of Helsinki (latest version) A Guide to Clinical Drug Research: 2nd Edition, A. Cohen & J. Posner (2000), ISBN: 0-7923-6172-5 (recommended) Study designs Pharmacokinetic principles The most current copy of the ICH Guidelines and other regulatory materials may be found on the following Web sites: 1. Declaration of Helsinki* (latest version on the Web site) http://www.wma.net/e/policy/b3.htm 2. ICH Guidelines (e.g. E2—Clinical Safety, E6—GCP) http://www.ich.org/ *Note of clarification on paragraph 29 of the WMA Declaration of Helsinki. The WMA is concerned that paragraph 29 of the revised Declaration of Helsinki (October 2000) has led to diverse interpretations and possible confusion. It hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm. All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review. An online European/ICH CRC practice exam is also available from the Online European/ICH CRA Practice Exam Web site at

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http://www.acrpnet.org/MainMenuCategory/Certification/ExamPreparation/ICHEUPracti ceExams.aspx

CRC Sample Exam Questions
The following samples show the type of questions that will appear on the CRC Exam. 1. Which of the following does not require IRB/IEC approval? A. Investigator's drug brochure B. Addendum to an approved informed consent C. Advertisement for subject recruitment D. Amendment to an approved study protocol 2. Which of the following would be considered a Serious Adverse Event? A. Migraine headache B. Stroke with hemiplegia C. Maculopapular rash treated with cortisone cream D. 12-hour observation in an emergency room for a bee sting 3. Which of the following documents must be evaluated for approval by the IRB/IEC? 1. Investigator's Brochure 2. Protocol 3. Laboratory certification 4. Informed consent form A. 1 and 3 only B. 2 and 4 only C. 1, 2, and 3 only D. 1, 3, and 4 only 4. Which of the following is true regarding the study protocol? It must: A. Contain information on the bio availability of the investigational product B. List the name and address of the responsible ethics committee(s) C. Include a description of the statistical methods to be employed D. Define the quality assurance auditing procedures Answers 1. A; 2. B; 3. B; 4. C

Contact Information
All correspondence and requests concerning CRC exams or Certification Maintenance should be directed to: The Academy Certification/Certification Maintenance Department 500 Montgomery Street, Suite 800 10

Alexandria, VA 22314-1560 Tel: (703) 254-8100 Fax: (703) 254-8101 E-mail: certification@acrpnet.org These requests may include: change of address, change of test center location, admission ticket was not received, duplicate score report, hand scoring of the answer sheet and cancellation request. All fees must accompany the request.

Non-Discrimination Policy
The Academy does not discriminate on the basis of age, gender, race, disability, marital status, sexual preference, religion, or national origin.

Discipline and Complaints Policy
The Academy enforces the ACRP/APPI Uniform Code of Ethics and Professional Conduct for all CRA, CRC, and CTI certificants and individuals in the process of obtaining CRA, CRC, or CTI certification. The Academy will investigate reported violations of the Uniform Code of Ethics and Professional Conduct. Complaints regarding alleged violations should be reported to the Academy in writing and should include a detailed description of factual allegations supporting the charges and any relevant supporting documentation. Information submitted during the compliant and investigation process is considered confidential and will be handled in accordance with the Academy’s Confidentiality policy. Adverse disciplinary decisions made by the Academy (or its sub-committees) may be appealed. A complete copy of the Discipline and Complaints policy and procedure and the Appeal policy and procedure may be requested by contacting the ACRP.

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