ROLES AND RESPONSIBILITIES OF CRC Flashcards
what is IIT?
Investigator-Initiated Trial
- includes a CT team ; PI, INV, CRC
what is CRC?
CLINICAL RESEARCH COORDINATE :
- A specialized research professional working with, & under the direction of, the Clinical Investigator
- handles the bulk of daily CT activities
CLNICAL INVESTIGATOR :
- legally responsible for the management of CT at a site
what do you need to become a CRC?
medical prof : Nurses, physician assistants
non-medical prof : science background and experience- based training
training of CRCs?
- on-the-job training by experienced CRCs
- sponsor companies ; protocol/study-specific
- investigator meetings ; formal presentations/informal interactions
- formal training course
personalities of CRC?
administrative
business
medical
patient-oriented
skills of CRC?
- have extremely good organization skills
- be detailed-oriented and people-oriented
- self-confident, flexible and adaptable to change
- focused, manage time well and follow through problems and commitments
- high energy level
roles of CRC?
- assist in evaluating new protocol for feasibility at the site
- prepares the site for conducting the study
- participate in informed consent process
- manages study conduct throughout the trial
A
- review the protocol, IB, consent form, subject eligibility requirements
- ability to meet the study timelines in light of other site commitments and overall feasibility
- assess the resources necessary to do the study - people, physical space, material
B
- train the people involved
- set up and organize study files
- prepare documents for submission to ethics committee
- collect the documents needed to initiate the study
- attend investigator meeting
C
- assist in writing consents
- present and discuss the informed consent form to potential subjects and answer their questions
- ensure that all necessary signatures and dates are obtained correctly in the informed consent forms
- document, distribute and file signed informed consent forms appropriately
D
- recruit subjects
- schedule subject and sponsor visits
- contact and screen potential subjects
- prepare for each subject visit to ensure that all appropriate study procedures are done
- resolve data queries
- record study supplies as necessary
others
- maintain regular communications with sponsors/CROs, RA, and the institution
- solves problems
- collaborate with other department as necessary
- assist the investigator with financial aspects of the trial including budgeting and contracts
key responsibility of CRC?
CRC must conduct all trial activities according to the appropriate regulations
- must ensure patient safety and well-being
career options for CRC?
- in-house clinical trial division in pharmaceutical companies
- CRO
- CTU in hospitals
- CRC in specific departments/services
- RA
what is CTA?
CLINICAL TRIAL ASSISTANT
- work with the pharmaceutical companies/CROs
- administrative position
- support the clinical team in managing CT projects
