The Clinical Research Coordinator (CRC) is often responsible for coordinating activities
within the institution when implementing study logistics. These include interactions
with the Principal Investigator (PI) and subinvestigators, clinic and in-house scheduling
offices, clinical and special laboratories, and other departments (e.g., ER [emergency
room], ICU [intensive care unit], and Radiology Department), as well as the grants
administration office and the Institutional Review Board (IRB).
THE PRINCIPAL INVESTIGATOR AND
The PI is ultimately responsible for communications regarding the clinical trial. However,
it is often the CRC who is more intimately involved with the details of the study. It is
imperative that there be open communication and clear delineation of responsibilities
between the PI and CRC. Also, essential study information must be disseminated to all
subinvestigators to assure that the study proceeds as smoothly as possible and according
to protocol. Table 5.1 provides suggestions to facilitate communication about the study
to all research staff involved.
THE INSTITUTIONAL REVIEW BOARD
The policies of IRBs at each institution may differ. The CRC will need to become familiar
with the policy of the institution. However, all IRBs are required to adhere to FDA
regulations (see Chapter 2 and Appendix A, 21 CFR 56).
At some institutions, the investigator and/or CRC are requested to attend the meeting
of the IRB when their project is being discussed. At others, the investigator1CRC may
© 2002 by CRC Press LLC
104 Clinical Research Coordinator Handbook
TABLE 5.1 FACILITATING STUDY COMMUNICATION
Schedule regular, periodic meetings with the PI and subinvestigators to discuss the trial
Circulate a draft agenda prior to the meeting and request that participants submit items for the
Stick to the agenda at the meeting but also allow time for unanticipated items.
Some suggested areas to discuss: Patient accrual, adverse events, responses, amendments or
changes to the study, information from the sponsor, specific problem areas.
Submit regular periodic reports to the PI.
Particularly, you may want to keep the PI updated on such things as accrual rates, adverse events, specific
Develop a centralized computer database that study personnel can access.
Have multiple copies of the protocol, study procedures manual, study schema, and relevant study
aids available for all study personnel.
Keep additional copies in areas where they may be easily obtained, e.g., central office area, clinic exam
rooms, etc., but remember to maintain confidentiality by limiting access.
Develop study aids.
Develop charts, flow sheets, study schemas, schedules of evaluations and visits, study pocket cards (see
Figure 3.1, Table 7.1, and Appendix D), forms, graphs, and lists that easily communicate aspects of the
be asked to not attend if their research is being discussed unless he/she is needed to
clarify questions. In any case, an investigator/subinvestigator who sits on an IRB may
not vote on any research in which he/she is involved.
The IRB needs to be updated periodically on the progress of the study. The IRB
must be notified of Serious Adverse Events and patient deaths (see Chapter 8). Also,
IRBs require at least an annual progress report (sometimes more frequently, depending
on the risk involved and IRB policy) and renewal of approval at the anniversary of the
initial approval date. The investigator is required to submit all amendments to the
protocol (modifications to the research study) to the IRB and obtain approval of the
amendment prior to implementation. Amendments affecting subject safety, i.e., removing
a hazard, may be implemented prior to IRB notification but must be submitted in a
Maintain all documentation of communication with the IRB in the study file.
Chapter 2 discusses the regulations as they pertain to interactions with the IRB.
© 2002 by CRC Press LLC
Interactions Within the Institution 105
One of the major responsibilities of the CRC is working through the logistics of study
implementation, i.e., the day-to-day activities of performing a clinical trial. Working
through the study logistics is probably the most critical task in a clinical trial. It is
possible that the protocol may require changes because it would not be feasible to do
something as written. This usually requires a great deal of organization, cooperation,
ingenuity, and, sometimes, a little coercion!
When: Study logistics should be evaluated at some point between the prestudy
visit and prior to the initiation visit. The CRC should be prepared to walk-through
the procedures at the initiation visit with the monitor.
What: Table 5.2 contains some of the areas that the CRC will need to coordinate
within the institution.
Most of these items are discussed in greater detail in other areas of the handbook.
Refer to Chapters 3 and 4 for additional information on study procedures involving
other areas of the institution.
PREPARING HOSPITAL STAFF
Often, it will be necessary to conduct the clinical trial in a hospital setting where hospital
staff will be involved. The nursing staff involved must be informed of the study pro-
cedures. Some ways to accomplish this are as follows:
Have an in-service meeting to discuss the study. Be specific about what responsi-
bilities the nursing staff will have-administering the test agent, observing for
adverse events, collecting vital sign data and test samples.
Provide standard Physician's Orders for study subjects.
Provide a protocol-specific checklist to attach to the subject's chartldaysheet. It
is helpful to use a distinctive color of paper to set the list apart from all other
Let the subject know what the study-specific procedures are-the subject may
be able to remind the staff of sampling time when necessary.
Discreetly label the subject's chart, daysheet, bed, wristband (anything and
everything that makes sense!) to alert staff that this is a study subject.
© 2002 by CRC Press LLC
106 Clinical Research Coordinator Handbook
TABLE 5.2 AREAS OF INSTITUTION COORDINATION
Administrative Includes IRB approvals, advertising, study file maintenance.
Subject Screening How will study subjects be identified and screened? Will special screening clinics
Subject Referrals Notify appropriate specialty areas within the institution for subject referrals. Are
subjects to be identified or enrolled through such areas (e.g., ER, CCU)?
Subject Visits How are visits to be scheduled? Is there adequate space? Plan the subject's day
. . . how will the visit flow from assessment to labs to special tests, etc.?
In-House Subjects If subjects are to be admitted to the hospital, what will the procedure be? Notify all
staff on the floor of specific study procedures. Place brightly colored instruction
sheets in the subject's chart.
Subject Billing What arrangements are made to assure the subject is not billed for procedures that
are study related?
Obtaining Lab Will the lab be available for tests during subject visits? Is it close by? Will it create a
Tests bottleneck in the flow of the subject's visit? Can priority be given to study subjects?
Medical Records Are medical records readily obtainable? How much lead time is needed? How long
are medical records maintained by the institution? Does this meet regulatory
requirements for record retention? Per FDA regulations, source documents must
be kept for the same time period as study files. What happens to a subject's file
after a death?
Completing Determine what is necessary to include in the subject's medical record or clinic
Medical chart. Is an originalsigned Informed Consent Form required (the subject may need
Records to sign many copies)?
Dispensing Will the investigational agent be dispensed through the pharmacy? If so, is it open
Investigational at the time of subject visits? Will the pharmacy be responsible for randomizing
Agent subjects? Does the pharmacy keep the code-breaker? Is a pharmacist available 24
hours in case of an emergency? Is the pharmacist qualified to dispense drug; does
heishe know the study? Where and how will the drug be stored? Will the pharmacist
maintain records as required?
Other Sites Sometimes your institution will be the coordinating site for a large multicenter trial
or a cooperative group effort. In this case, who will be responsible for shipping study
drug, screening and enrolling subjects, coordinating data?
Tests Done by How will subjects be scheduled? How will the department be compensated? Will
Other Departments someone consistently be reading the test? What is the report turnaround time and
Subject Will subjects be compensated? How? Is compensation contingent on study adher-
Compensation ence and completion?
Grants Is there a specific department in the institution that handles all grants? What is its
Management role? Does it make payments as well?
Legal Issues The legal department may be involved with negotiating contracts and indemnification
© 2002 by CRC Press LLC
Interactions Within the Institution 107
Provide prelabeled sample collection vials and other study-specific materials.
Develop a team approach with the staff and be sure to follow up periodically so
that any errors or omissions can be caught early and corrected.
Collaborating with Colleagues (Part I): Staff Nurse Involvement. Tonya Edens and Karen
Safcsak, Research Nurse, Vol. 4 (4), pp. 4-8, 1998.
Issues in the Review of Clinical Drug Trials by IRBs. D. Cowen. In Clinical Drug Ti-ials
and Ti~ihulatiorzs, by Allen Cato, Marcel Dekker, Inc., New York, pp. 32 1-345, 1988.
Learning to Conduct Research-The Hard Way. L. Witter, RN, February, pp. 3 5 4 0 ,
Negotiating Clinical Trial Agreements with Academic Institutions. G. Sanders, Applied
Clinical Ti-ids, Vol. 1 (6), pp. 39-45, 1992.
The Interrelationships of Sponsors, Clinical Investigators, and Institutional Review
Boards. T. Kirsch, Drug Iifornzatiorz J O L ~ IVol. 21 (2), pp. 127-1 3 1, 1987.
The Role of the Coordinating Center Project Manager in a Multicenter Clinical Trial.
S. Margitic, Jourrzal of Clinical Research and Drug Development, Vol. 7 (4), pp. 243-
© 2002 by CRC Press LLC