Role of CRC1

8/7/2019 Role of CRC1

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Role of a Clinical ResearchCoordinator / CRA


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D efinition of a CRC

` "A Clinical Research coordinator, Study Site Research Nurse or Study SiteCoordinator, works at a clinical researchsite under the immediate direction of a

principal investigator, whose researchactivities are conducted under Good Clinical Practice regulations.


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Although the clinical investigator is legallyresponsible for the management of the clinical

trial at the site, the CRC handles the bulk of the daily activities and plays a critical role instudy conduct.


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What is a Clinical ResearchCoordinator (CRC)?

` Specialized research professional` Manages daily operations of a clinical` investigation` Works with and under the direction of the PI whose

research activities are conducted under Good ClinicalPractice (GCP)

` Plays a critical role in the study conduct` Has a wide range of responsibilities


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Advantages of having a CRC

` Increase recruitment rate` Enhancement of retention` Good data quality` Increases general study efficiency


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Clinical Research Associate (CR A)` professional who administers and monitors the progress

of a clinical trial (pharmaceuticals, biologics, or devices)on behalf of a sponsor


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CRC / CR A Qualifications` nursing or in a science or health field and have knowledge

of research., medical professionals` Msc in Life Sciences/MBBS 1-3 years of clinical research


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Responsibilities of CRC / CR A ` General Responsibilities` Capacity building` Training of new CRC / CRA s


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Responsibilities of CRC / CR A ` Trial Specific Responsibilities1. Site identification2. Pretrial documentation3. IRB4. Regulatory5. Financial M anagement6. General Ad mini s trative


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Responsibilities of CRC / CR A 7 . Training of the site staff 8. Informe d C on s ent P roce ss9 . S ite initiation vis it s10 . Inve s tigator s M eeting11 . I C F, S creening an d recruitment / enrollment12 . S che d uling of vis it s


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Responsibilities of CRC / CR A

13. Research pharmacy and drug/device accountability14. Laboratory15. Amendments16. Monitoring


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G eneral Responsibilities


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C apacity building` To ensure that the pool of potential investigators and

sites keeps increasing` Lookout for new sites with new investigators` Visiting new sites and evaluating their capability to

participate in global clinical trials


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C apacity building

` Assesment of :i) Manpower presence and competenceii) Support staff and constatnt supportiii) Infrastuctureiv) Presence of functional ethics committeev) Compatible managementvi) Major disease incidence and prevalence rates


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T raining of new CRC / CR A s` Training in every field of the trial

` Training programmes in data management, report writing,EDC areas


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T rial Specific Responsibilities


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Site identification` Factors involved are :-1. Reputation of the investigator in his / her field2. Previous clinical trials conducted at the site3. Site infrastructure4. Type of organization5. Type of IRB and meeting frequency


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Site identification

6. Access to patient population needed for the trial7 . Access to the sponsor8. Anticipated time required for trial initiation9. Anticipated time required for trial completion10.Patient turnover11. Cost of the trial12. Geographical location of the site


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Site identification

Assess Physician qualifications:` Current CV and medical license for the principal investigator` What is the physicians specialty/subspecialty?` What is experience in conducting clinical trials?` Has he been audited by regulatory authorities or sponsors

previously?


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Site identification

Adequate Staff to properly conduct the trial` Define who will do what for the study

` Study coordinator` Sub-investigators` Data Managers

` How much time do you have for the study?` How many trials are you currently working on?` How much experience do you have in conducting clinical trials?


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Site identification

Adequate Facilities` Exam rooms` Pharmacy/Study drug storage area` Laboratory or specimen processing area` Special testing areas ( x-rays, CT scans, endoscopy, etc.)` Record keeping facilities


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Site identification

O verall Site Assessment` Type of IRB and meeting frequency` Contract execution requirements` Source documents (paper vs. computerized)` Monitoring facilities


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P retrial documentation

` Collects documents needed to initiate the study andsubmit to the sponsor

` FDA Forms 15 7 2,` Updated and signed CVs` Financial d is clo s ure` Undertaking from the Investigator


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I RB

` Collect relevant information about the IRB` Presence of written S O P` Membership list` Submission requirements` Reporting timelines for safety reports and interim reports` F inancial requirements for submission


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I RB` Ensure timely submission of the IRB documents` Follow up with the IRB for faster approvals` timely submission of all safety reports and amendments

to the trial documents` O btain acknowledgement letters from IRB


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Regulatory

` Collaborates with the PI to prepare IRB and any otherregulatory submission documents as required by theregulatory body

` Ensure the receipt of favorable approval from the

regulatory authorities and proper filing of the same at thesite and dispatch to the concerned personnel of theSponsor


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Regulatory ` Ensure timely submission of all safety reports and

amendments to the trial documents` O btain acknowledgement letters from the regulatory

authorities


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F inancial Management

` Coordinates appropriate and timely payments toparticipants

` Negotiates trial Budget at the site:` Investigator fees` IRB fees` Lab cost` Study subject travel and other reimbursements`

Any other trial specific Budget


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G eneral Administrative

` Collaborate with other departments as necessary andparticipate in problem solving

` Help in the prestudy setup of clinical trial site


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T raining of the site staff ` Assists the PI in development of materials and tools

necessary to appropriately train individuals` Maintains documentation of training.


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T raining of the site staff ` CRC can undertake frequent training sessions with the

site team on :-` Inclusion and exclusion criteria` Schedule of visit and visit specific activity` Safety guidelines as per protocol , safety reporting

timelines and importance of timely reporting of SAEs


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Informed Consent Process` Interact with the investigator, sponsor and/or IRB on

informed consent wording issues Review informed consent document for quality andcompleteness

Ob tain informe d con s ent` Coordinate the re-consent process as needed


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Site I nitiation Visit

Site Preparation for an SIV` Ensure all supplies have been received prior to the visit.` Schedule a room for the meeting` Block adequate time for the visit

` Ensure investigator is available for the visit (typically about 1hour).


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Site I nitiation Visit

` Notify all appropriate staff of the visit including the pharmacist` Have the regulatory binder up to date and ready for review.` Prepare the Delegation of Authority form in advance of the

visit


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I nvestigators Meeting` The meeting typically includes clinical research associates,

clinical research coordinators, clinical investigators,medical monitors, quality assurance and seniormanagement.

` to conduct protocol and GCP training and allowparticipants an opportunity to ask questions about clinicaltrial conduct.


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ICF, Screening and recruitment /enrollment

` Follow up with the site team to enroll faster andcomplete the enrollment within the timelines.

` The CRC present at the site during enrollment processensures that:

` The IC F conforms to the ICH GCP guidelines` ICF is read out to the study subject or to his / her legally

acceptable representatives as applicable.


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ICF, Screening and recruitment /enrollment` the study subject is given adequate time and opportunity

to put forth his/ her queries` All queries are clarified upto his / her satisfaction` The IC F is signed , dated and timed as per the sponsors

specific SO P / guidelines` A copy of signed IC F is handed over to the study subject` The site copy of the IC F is filed in the appropriate section

of The TM F


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Scheduling of visits` Usually undertaken by CRC and not by CRA` CRC ensures that the study subject are informed about

their Schedule of visits well in advance` Prepare protocol specific visit calendars` Assist investigator with study subject visits


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` Use friendly formats of the visit calendars` Brief subjects on the importance of completing the entire

trial and prevent missed visits` Follow up with subjects prior to the scheduled visits to

ensure that they make the visits on date and time


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Research pharmacy and drug/deviceaccountability

` CRC has to Ensure drug/device accountability` At the initiation of the trial, he/she takes the responsibility

of the stock and ensures that the entire materials are ingood condition and in appropriate quantity

` Store materials in the appropriate place at the site


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Research pharmacy and drug/deviceaccountability

` Restrict accessibility to the storage room to onlyauthorized personnel related to the trial

` Ensure that the storage conditions are maintained as perthe specification mentioned in the protocol

` Ensure that the daily recording of the temperature ,humidity , are maintained and recorded on a daily basis


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L aboratory

` CRA /CRC evaluates the capability of the laboratory atthe trial site

` Laboratory is visited to assess:` Availability of trained technical manpower` Provision to conduct the protocol specified range of tests` Pre analytical requirements and timelines` Facilities for timely pick up of samples from the sites


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L aboratory

` Accreditation and certification and their respectivevalidity

` Collection and filing of all essential documents- CV of Lab Director and other key members- Normal values for the protocol specific range of tests- -lab manual- Collection centers and contact details


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A mendments

` For all protocol amendments the CRC/CRA follow upwith the sponsor for the amended versions.

` All ICF amendments the CRC/CRA follow up with thesponsor for the amended versions.

` All completed subjects must be informed about ammendin ICF

` All continuing subjects must be informed about ammendin ICF. Reconsent has to be taken with new version of

ICF


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E ssential Skills of a C RA / C RC

` O rganisational, IT & administrative skills` Attention to detail` Communication written & oral` Self Motivation` Ability to motivate others` Time management` F

lexibility & versatility


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T hank You

Role of CRC1

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