Role Of Clinical Research Coordinator

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Discusses the CRC job function. Specifically the tasks performed by a CRC and the consequences of non-conformance.

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By: shraddha
1003 days 17 hours 19 minutes ago

Presentation Transcript

The Role of the Clinical Research Coordinator : The Role of the Clinical Research Coordinator Sarah Wilson, BS., MS., CCRP President WQATS, LLC Certified Trainer

The Role of the Clinical Research Coordinator (CRC) : WQATS,LLC (c) copyright 2008 2 The Role of the Clinical Research Coordinator (CRC) We will discuss: What the Regulations and Good Clinical Practices (ICH Guidelines) say about the Clinical Research Coordinator. The Clinical Research Coordinator legal consequences. The REAL story about the Clinical Research Coordinator. The Clinical Research Coordinator commitment and ‘real life’ responsibilities.

Slide 7 : WQATS,LLC (c) copyright 2008 7 I am unaware of any regulation or guideline that defines the responsibilities of a Clinical Research Coordinator. The Role of the Clinical Research Coordinator (CRC)

Slide 8 : WQATS,LLC (c) copyright 2008 8 U. S. Regulations governing clinical research for drugs, medical devices and biologics clearly places the responsibility of research compliance with the: IRB/IEC Sponsor Investigator Monitor The Role of the Clinical Research Coordinator (CRC)

Slide 9 : WQATS,LLC (c) copyright 2008 9 With no mentioning of a CRC in the regulations or guidelines, how does the CRC end up with ‘responsibilities and commitments’ in clinical research? The Role of the Clinical Research Coordinator (CRC)

Slide 10 : WQATS,LLC (c) copyright 2008 10 ICH E-6 Good Clinical Practices for Industry statement that applies to the CRC… ICH E6 4.1.5 - The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties. The Role of the Clinical Research Coordinator (CRC)

Slide 11 : WQATS,LLC (c) copyright 2008 11 Title 21 CFR 312 refers to the investigator delegating responsibilities to a “sub-investigator”. Title 21 CFR 312.53 Will ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above commitments. Investigator should maintain a list of the names of the sub- investigators (e.g., research fellows, residents) who will be assisting the investigator in the conduct of the investigation(s). The Role of the Clinical Research Coordinator (CRC)

Slide 12 : WQATS,LLC (c) copyright 2008 12 Regulatory definition of a sub-investigator: (ICH E6): ANY individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). The Role of the Clinical Research Coordinator (CRC)

Slide 13 : WQATS,LLC (c) copyright 2008 13 Regulatory definition of a sub-investigator: (21CFR 312 Definition): Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. "Subinvestigator" includes any other individual member of that team. The Role of the Clinical Research Coordinator (CRC)

Slide 14 : WQATS,LLC (c) copyright 2008 14 Regulatory definition of a sub-investigator: (21CFR 812.3): Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. The Role of the Clinical Research Coordinator (CRC)

Slide 15 : WQATS,LLC (c) copyright 2008 15 The CRC’s responsibilities are those delegated by the investigator. The CRC should receive clearly delegated duties in writing from the PI. The PI is required to ensure the CRC is qualified by experience and training to perform delegated duties. (21 CFR 312.5g) The Role of the Clinical Research Coordinator (CRC)

Slide 16 : WQATS,LLC (c) copyright 2008 16 Can Clinical Research Coordinator’s be held ‘legally’ accountable for clinical research that they help conduct? The Role of the Clinical Research Coordinator (CRC)

~CRC Accountability~ : WQATS,LLC (c) copyright 2008 19 ~CRC Accountability~ Paul H. Kornak Stratton VA Medical Center, Albany, New York (Federal Register: February 24, 2006; Volume 71, Number 37): ….. The Role of the Clinical Research Coordinator (CRC)

~CRC Accountability~ : WQATS,LLC (c) copyright 2008 20 ~CRC Accountability~ From May 14, 1999 to July 10, 2002, in connection with the XYZ protocols, Mr. Kornak participated in a scheme to defraud the sponsors of the clinical studies in that ``he would and repeatedly did submit false documentation regarding patients and study subjects and enroll and cause to be enrolled persons as study subjects who did not qualify under the particular study protocol.'' Mr. Kornak caused the death of a study subject when he ``failed to perceive a substantial and unjustifiable risk that death would occur when he knowingly and willfully made and used documents falsely stating and representing the results of [the study subject's] blood chemistry analysis”… The Role of the Clinical Research Coordinator (CRC)

~CRC Accountability~ : WQATS,LLC (c) copyright 2008 21 ~CRC Accountability~ Court’s Decision: Mr. Kornak is excluded for life from participating in any and all Federal agency transactions, both procurement and non-procurement, as set forth in U.S. regulations part 76. Permanent Debarment! The Role of the Clinical Research Coordinator (CRC)

Slide 22 : WQATS,LLC (c) copyright 2008 22 Dr. Robert Fiddes: Family practitioner turn researcher. Tired of managed care. To restricting. Also a lawyer. Passed the bar in 1987. President, owner, and Principal Investigator of Southern California Research Institute (SCRI). Performed clinical trials related to high blood pressure, migraine, asthma, diabetes, and other medical conditions. Conducted over 200 studies for as many as 47 drug companies beginning in the early 1990s. The Role of the Clinical Research Coordinator (CRC)

Slide 23 : WQATS,LLC (c) copyright 2008 23 Dr. Robert Fiddes (and his research staff) To date, the most elaborate case of research misconduct known in the history of USA clinical trials. Three (3) CRCs legally affected. Accused of the following misconduct: Rigging medical tests. Inventing subjects. Using an employee’s urine to obtain lab data and enter subjects into studies (needed high levels of protein). Enrolled themselves and members of their families into several studies at once to get the ‘recruitment bonuses’ offered by the sponsors. The Role of the Clinical Research Coordinator (CRC)

Slide 24 : WQATS,LLC (c) copyright 2008 24 Names of the 3 Clinical Research Coordinators were: Laverne Charpentier (Head Coordinator) Delfina Hernandez Elaine Yee-Ling Lai All 3 found guilty of fraudulent practices Coordinators admitted to: Falsely reporting certain subjects participated in clinical trials when in fact, they had not; Substituting samples and data from qualifying subjects for non-qualifying subjects; and Enrolling nonexistent and non-qualifying subjects in the clinical studies and falsified data for those nonexistent and non-qualifying subjects. The Role of the Clinical Research Coordinator (CRC)

Slide 25 : WQATS,LLC (c) copyright 2008 25 Dr. Fiddes laid much of the blame on his study coordinators for everything that happened (The New York Times, May 1999). Without providing evidence to support the assertion, and while documentation showed he was the beneficiary of the illegal activity; Dr. Fiddes maintained that it was the salaried employees working for him who devised the frauds, often without his knowledge. Statements not found to be credible and no further investigation ensued. The Role of the Clinical Research Coordinator (CRC)

Slide 26 : WQATS,LLC (c) copyright 2008 26 Court’s Decision (September 30, 1997: Delfina Hernandez - Debarment order = 5 YEARS (Debarment order rescinded January 3, 2003 after FDA discovered the order for debarment was sent to the wrong person with the same name. Her name has been removed from the debarment list). Elaine Yee-Ling Lai - Debarment order = 5 YEARS (Pled guilty June 9, 1998; debarred by FDA November 13, 2002. Did not request hearing.) The Role of the Clinical Research Coordinator (CRC)

Slide 27 : WQATS,LLC (c) copyright 2008 27 Court’s Decision (September 30, 1997: Laverne Charpentier - Debarment order = 5 YEARS (Pled guilty October 27, 1997; debarred by FDA December 2, 2002. Request for a hearing denied.) Robert Fiddes, M.D. Debarment order = 20 YEARS (Sentenced September 30, 1997; debarred by FDA on October 15, 2002. Did not request hearing. Served 15 months in jail.) The Role of the Clinical Research Coordinator (CRC)

Slide 28 : WQATS,LLC (c) copyright 2008 28 Vickie L. Hanneken, R.N.: Decatur Memorial Hospital, Illinois. Discovered by the staff at DMH and reported to the Office of Research Integrity. Committed 60 separate acts of falsifying or fabricating data in the clinical/study records of 35 participants. The Role of the Clinical Research Coordinator (CRC)

Slide 29 : WQATS,LLC (c) copyright 2008 29 Vickie L. Hanneken, R.N., Decatur Memorial Hospital: Court’s Decision: Voluntary Exclusionary Period (debarment) for 3 years beginning March 15, 2004. The Role of the Clinical Research Coordinator (CRC)

Slide 30 : WQATS,LLC (c) copyright 2008 30 Jessica Lee Grol: University of Pittsburgh; November 23, 2005, Fabricated study research records for 15 subjects, including the Subjects interview data. Subjects’ data tracking form. Medical record extraction data in a study on the management of cerebral aneurysms. The Role of the Clinical Research Coordinator (CRC)

Slide 34 : WQATS,LLC (c) copyright 2008 34 The perfect Clinical Research Coordinator! Nurse Doctor Physician Assistant Adequately trained medically trained personnel The Role of the Clinical Research Coordinator (CRC)

Slide 35 : WQATS,LLC (c) copyright 2008 35 Skills & Personality: Realistically Speaking – The CRC Job is Multifaceted Administrative Business Medical People oriented Good organizational skills Ability to multi-task Attention to details The Role of the Clinical Research Coordinator (CRC)

Slide 36 : WQATS,LLC (c) copyright 2008 36 Tasks generally delegated to CRCs include…. Recruitment Reviewing new protocols Training/mentoring additional staff Preparing the site for the clinical trial Developing the informed consent form/document Executing the informed consent Investigational product accountability The Role of the Clinical Research Coordinator (CRC)

Slide 37 : WQATS,LLC (c) copyright 2008 37 Scheduling visits and seeing subjects. Maintaining clinical trial documents/records. Interacting with IRB/CRO/Contract Labs/Sponsor. Developing and executing study budget. Hosting Monitors/Auditors/Inspectors. Finding new studies for the research practice. Keeping the investigator informed and compliant. In essence, CRC’s MANAGES the clinical trial!! The Role of the Clinical Research Coordinator (CRC)

Slide 38 : WQATS,LLC (c) copyright 2008 38 Summarily, with the exception of activities requiring “medical decisions” (such as physicals, AEs/SAEs, lab significance, etc.) the responsibilities described in the ICH-E6 delegated to the investigator (Section 4) are generally passed on to the CRC. The Role of the Clinical Research Coordinator (CRC)

Slide 40 : WQATS,LLC (c) copyright 2008 40 (if delegated to you…) Review the protocol, IB and other study materials submitted by the sponsor. Determine, if based on protocol requirements, and a ‘preliminary assessment’ of medical charts if the PI has patients who meet the criteria and can become subjects in the clinical trial. Compile your information and present to the PI so he/she can decide whether or not to do the trial. The Role of the Clinical Research Coordinator (CRC)

Slide 41 : WQATS,LLC (c) copyright 2008 41 Compare the IRB/IEC requirements to the protocol requirements. If they differ, remember you’re required to meet both. If the Sponsor takes on some of the IRB/IEC reporting responsibilities, ensure copies are sent to you for the site’s regulatory files. Make a list of study-related questions (from protocol, IB, CRF, etc.) that need clarification and ask them before the study start…..Investigator Meetings are the best place to ask these questions! The Role of the Clinical Research Coordinator (CRC)

Slide 42 : WQATS,LLC (c) copyright 2008 42 Follow the protocol. Ensure the PI’s involvement. Schedule times to review study progress with the PI. Schedule the PI’s visits with the Monitor. Schedule your day to allow time with the Monitor. Document meeting/discussion (i.e. minutes) with the PI and have him/her initial it. At a minimum, document date, time, name of meeting attendees and topics discussed. Maintain this as a record of PI involvement in case of an inspection. The Role of the Clinical Research Coordinator (CRC)

Slide 45 : WQATS,LLC (c) copyright 2008 45 Not all elements of the Informed Consent were incorporated. Study procedures were conducted before the consent was signed. Not all signatures performed appropriately. For example, some site personnel write the subject’s name on the ICF and let the subject sign the form. Some allow subjects to sign at home instead of in their presence. The Role of the Clinical Research Coordinator (CRC)

Slide 46 : WQATS,LLC (c) copyright 2008 46 Avoid the problem! Create a template that contains all of the elements of 21 CFR Part 50. Study specific information can be incorporated as appropriate. Ensure the language of the consent will be understandable by the potential subjects. Allow subjects sufficient time to ask questions. The Role of the Clinical Research Coordinator (CRC)

Slide 47 : WQATS,LLC (c) copyright 2008 47 Samples of writing in a language understandable to the subject: Teaspoon (instead of milliliters). Measure your waist (instead of waist circumference). Sick to the stomach (instead of nausea). The Role of the Clinical Research Coordinator (CRC)

Slide 48 : WQATS,LLC (c) copyright 2008 48 The Office of Civil Rights (OCR) is responsible for enforcing compliance with the Health Insurance Portability and Accountability Act (HIPAA). Study subjects must be made aware that their personal health information (PHI) maybe discussed with other clinicians, reviewed/copied by the sponsor and regulatory authorities. The Role of the Clinical Research Coordinator (CRC)

Slide 49 : WQATS,LLC (c) copyright 2008 49 Names Addresses Employer name/address Relatives name/address All elements of dates associated with a person Telephone/Fax numbers Email addresses Social Security Number Medical record numbers Certificate numbers (including device serial numbers) Member or account numbers Certification/license numbers Voiceprints Fingerprints Vehicle numbers Biometric identifiers Full face photos Any unique identifying numbers, characteristic or code The following are considered PHI by OCR: The Role of the Clinical Research Coordinator (CRC)

Slide 52 : WQATS,LLC (c) copyright 2008 52 The Role of the Clinical Research Coordinator (CRC) “The patient fell out of the window and the site had difficulty getting drug”. “Patient came in for visit and said he had been in hospital with ammonia”. Protocol Inclusion/Exclusion Violation: Subjects 4, 5, 6, 7 & 8 were permitted to enter clinical trial ZZZ with high plasma results because there is no increased risk to the subject and if allocated the IP, I believe the subject will see benefit. Signed MD

Slide 53 : WQATS,LLC (c) copyright 2008 53 Create case histories that are complete and convey accurate information. Explain corrections made in the CRF and source documents to dates and measurements. Write the same information in each record to make sure the content matches. Explain/justify protocol deviations. Minimize the number of protocol deviations at your site. The Role of the Clinical Research Coordinator (CRC)

Slide 54 : WQATS,LLC (c) copyright 2008 54 Train! Train! Train! There is no substitute for knowledge and experience. Incorporate ‘checks and balances’ in your site practices to make sure the investigational plan (i.e. protocol, CRF guidelines, etc.) is followed and all inconsistencies resolved. Let your documentation tell “the site’s story”. The Role of the Clinical Research Coordinator (CRC)

Slide 56 : WQATS,LLC (c) copyright 2008 56 Develop SOPs and follow them. Standard Operating procedures are a testament to the way you do business and a sure way of obtaining data integrity. Not required by regulation but ‘expected’ by sponsors and the FDA. Ensures consistency in job performance. The Role of the Clinical Research Coordinator (CRC)

Slide 57 : WQATS,LLC (c) copyright 2008 57 Clarifies to staff the PI’s expectations for clinical trials. Clarifies to staff the PI’s delegation of responsibility (who does what). Describes the task and minimize micro-managing/training. The Role of the Clinical Research Coordinator (CRC)

Slide 59 : WQATS,LLC (c) copyright 2008 59 Disturbing Trends: High Turnover Rate! <3yrs at a site rose from 46% in 1999 to 56% in 2002. Changing career path and becoming CRAs. Changing careers altogether. Noticeable decrease in number of experienced CRCs. The Role of the Clinical Research Coordinator (CRC)

Slide 60 : WQATS,LLC (c) copyright 2008 60 Reasons for high turnover rate: Poor compensation. Burnout due to heavy workloads. Competitive hiring by other sites. Personal life changes. The Role of the Clinical Research Coordinator (CRC)

Slide 62 : WQATS,LLC (c) copyright 2008 62 Clinical researchers have two major goals: 1) Protect research subjects and 2) provide accurate data. Clinical Research Coordinators and anyone else performing clinical research activities can be debarred, fined and/or imprisoned for research misconduct. An investigator may delegate responsibilities to the clinical research coordinator, sub-investigator, research assistant and other staff members as he/she deem appropriate. The Role of the Clinical Research Coordinator (CRC)

Slide 63 : WQATS,LLC (c) copyright 2008 63 PI’s can delegate clinical trial responsibilities, but they can NOT delegate ‘trial accountability’. Trial accountability is always the responsibility of the principal investigator who signed the FDA Form-1572. The Role of the Clinical Research Coordinator (CRC)

Slide 64 : WQATS,LLC (c) copyright 2008 64 An investigator typically delegates the following task to the CRC: Assist with protocol review. Write consent forms. Recruit subjects. Explain the study to subjects. Obtain consent from subjects. Coordinate activities with relevant units. Collect and maintain clinical data. Serve as the main contact person for subjects during a study. Train other staff in the conduct of the study. The Role of the Clinical Research Coordinator (CRC)

Slide 65 : WQATS,LLC (c) copyright 2008 65 CRC’s primary responsibilities generally include: Subject recruitment. Subject consenting. Accurate data collection (i.e. completing CRFs, IP log, etc.) Maintaining required study documents. Getting and maintaining IRB approvals. The Role of the Clinical Research Coordinator (CRC)

Slide 66 : WQATS,LLC (c) copyright 2008 66 CRC’s primary responsibilities generally include: Providing the IRB with updates. Day to day problem solving. Hosting CRAs, Auditors and Regulatory Inspectors. Keeping the PI informed. The Role of the Clinical Research Coordinator (CRC)

Slide 67 : WQATS,LLC (c) copyright 2008 67 The Clinical Research Coordinator can be debarred if they commit scientific or research misconduct. The Clinical Research Coordinator should focus on data integrity and GCP compliance by ensuring accurate case histories are recorded and transferred to the Case Report Form. The Role of the Clinical Research Coordinator (CRC)

~WQATS, LLC Training Series~ : WQATS,LLC (c) copyright 2008 69 ~WQATS, LLC Training Series~ GCP-The Basics So You Want To Be an Investigator-Let’s Get Started! Becoming Certified as a Clinical Research Professional Embracing The Sponsor Audit and Minimizing Research Risk GCPs and the Investigator’s Responsibilities Human Research Subject Protection The Role of the Clinical Research Coordinator Investigational Drug Accountability and the Site’s Responsibility Creating Auditable Source Records Getting Started With Clinical Research Coordinating Investigators-Prepare for Your FDA Inspection Standard Operating Procedures and Clinical Research Achieving Compliance in a Sponsor-CRO Clinical Trial Collaboration The Role of the Clinical Research Coordinator (CRC)

References : WQATS,LLC (c) copyright 2008 70 References The CRC’s Guide to Coordinating Clinical Research, Wooden, K.E. (2004) ICH Consolidated Guidance: Good Clinical Practices for Industry (E6) Food and Drug Modernization Act The Role of the Clinical Research Coordinator (CRC)

Slide 71 : WQATS,LLC (c) copyright 2008 71 Thank You For Your Attention! For more training information, please contact me at wqats@ureach.com or 877-847-2186 The Role of the Clinical Research Coordinator (CRC)