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					                                INTERACTIONS WITHIN
                                  THE INSTITUTION

            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 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 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


            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
            problem areas.

            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
            timely matter.
                 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.

            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
                      chart papers.
                      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


            TASK                 DESCRIPTION
            Administrative       Includes IRB approvals, advertising, study file maintenance.

            Subject Screening    How will study subjects be identified and screened? Will special screening clinics
                                 be arranged?
            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-
            252, 1993.

© 2002 by CRC Press LLC

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