The Role of the CRC in a Clinical Trial

Transcription

1 The Rle f the CRC in a Clinical Trial Dr Saurendra Das Cuntry Head & Directr f Operatins, Excel Life Sciences The team cnducting a clinical trial at a site cnsists f the principal investigatr (PI), the c-investigatrs, and the clinical research crdinatrs (CRCs). Each persn in the team has a key rle t play. This site team is supprted by the spnsrs and cntract research rganizatin (CRO) teams. The US Fd and Drug Administratin (FDA) 1 and the internatinal guidelines fr Gd Clinical Practice (GCP) 2 and several ther guidelines clearly define the rles and respnsibilities f the investigatrs, spnsrs, and mnitrs. Hwever, very little frmal descriptin is available abut the critical rle played by the CRC. The Vital Link The CRC is a vital link between the research subjects and their family, the investigatr, and ther site team members. They are als the liaisn between the Spnsr, CRO, SMO, Central labratry, Curier, the Institutinal Review Bard (IRB), and ther players invlved in the trial. 1 Department f Health and Human Service: Investigatinal New Drug Applicatin. Respnsibilities f Spnsrs and Investigatrs, 21 Cde f Federal Regulatins Revised as f April 1, The Eurpean Agency fr the Evaluatin f Medicinal Prducts, ICH Tpic E 6. Guideline fr Gd Clinical Practice. Nte fr Guidance n Gd Clinical Practice (CPMP/ICH/135/95)

2 Only recently have research prfessinals realized the need fr having a trained research crdinatr at the site. Because f an increase in the number f clinical trials and the need fr cmplicated and data intensive research, many spnsrs tday are reluctant t place a trial at a site that des nt have a trained CRC t wrk alng with the investigatr. Whether they are called research crdinatrs, site crdinatrs, r clinical research crdinatrs, such individuals play a central rle in the smth and accurate cnduct f the clinical trial. RESPONSIBILITIES OF CRCs CRCs wrk in a team under the direct supervisin f the PIs. CRCs usually have t handle multiple respnsibilities. The respnsibilities f a CRC can be bradly categrized as: General respnsibilities Trial specific respnsibilities General Respnsibilities Capacity Building The wrk f the CRC begins the day he/she jins emplyment, whether r nt the spnsr has selected an investigative site fr any particular trial. The CRC ensures that the ptential pl f ptential Investigatrs and Sites keep

3 increasing. The CRC is always n the lkut fr new trial sites with Investigatrs wh are research naïve. They cnduct an in-depth survey f the new sites t assess: Manpwer presence and cmpetence Supprt staff and cnstant supprt Infrastructure Presence f a functinal Ethics Cmmittee Cmpatible management Majr diseases incidence and prevalence rates They analyze the data and share it with the Sales team f the rganizatin. This helps in leveraging the sales calls and sealing ff mre trial prjects in less time. This cllectin f data als helps in determining the number f sites t be undertaken fr a particular trial t ensure timely fulfillment f target. Training new CRCs Experienced CRCs are an asset and ften are the best persns t hand-hld and train the newcmers in the field f clinical research. The training may include cnducting feasibility studies, designing trial dcuments, setting up f sites, cnduct f the trial and trial clseut. Anther imprtant training mdule is the sft skill and managerial skills.

4 Trial - related Respnsibilities Site Identificatin A key respnsibility f the CRC is t identify the right site fr the trial ne that fulfills all the criteria set frth by the clinical trial guidelines and trial prtcl. A CRC wh has wrked at a particular site earlier is ften the best judge t identify the site fr anther trial. Having wrked at a site fr ver a perid f time, the CRC understands the needs, expectatins, and the ptential f the site. He/she knws hw the site can functin t its ptimum. What if the CRC des nt have prir experience at the site? Well, in such cases, a mre in-depth scrutiny f the site is required befre finalizing it fr any trial. There are several factrs that need t be cnsidered when identifying a suitable site fr a trial. Reputatin f the investigatr in the particular therapeutic area. Such infrmatin can be cllected based n peer views, references, publicatins, and previus experience in clinical trials Assess the site infrastructure t find ut abut availability f space, equipment, trained manpwer t handle particular equipment, ancillary facilities such as labratries, pharmacy etc, and cmmunicatin facilities. The Ethics Cmmittee/ IRB play a key rle in the cnduct f the trial. It must be ensured that the site has an IRB that wrks accrding the ICH GCP and ther applicable guidelines. The fllwing infrmatin needs t be cllected frm the IRB:

5 Presence f written SOP Membership list Submissin requirements Financial requirements fr submissin Turn arund time fr the apprval f the prtcl Evaluate the site s access t the apprpriate subject ppulatin whether the required number f subjects can be enrlled within the stipulated time. The spnsr, the auditr, and the trial inspectr may need t visit the site during the trial. Therefre, check the lcatin and access t prper transprt and cmmunicatin at the site. Pretrial Dcumentatin A CRC has t cllect the updated and signed resume f each member f the site team. He/She must ensure that the fllwing pretrial dcuments are cmpleted within the specified timeline: Frm 1572 Financial Disclsure Frm Undertaking frm the PI Cnfidentiality Nn-Disclsure Agreement Crdinating with the IRB Yu can actively fllw up thrugh the site team with the IRB fr a faster apprval f the trial. Yu will als lk int the timely submissin f all the safety reprts and the amendments f the trial dcuments t the IRB. Financial Respnsibilities

6 Smetimes a senir CRC may be empwered t negtiate the trial budgets at the site. This includes the investigatr fees, the IRB fees, the site administratin fees, labratry csts, study subject travel and ther reimbursements. Track the trial n a rutine basis. Infrm the cncerned persnnel n reaching specific milestnes. All milestne-related payments will be fllwed up by yu. Training the Site Staff The CRC must be ready t train the site staff n a regular basis thrughut the trial. He/she can highlight n: Inclusin criteria Exclusin criteria Schedule f visits Windw perid Visit specific activities Safety guidelines and reprting timelines as per the prtcl Investigatrs Meeting and Site Initiatin Visits The CRC may be in charge f cnducting the entire investigatrs meeting fr the trial. They als have t ensure that all the requirements are in place fr the site initiatin visit.

7 Infrmed Cnsent Frms The CRC ensures that the infrmed cnsent frm sent by the spnsr is translated and back-translated int the lcal language as advised by the investigatr. Patient recruitment and fllw up During the subject enrllment, he/she ensures that all queries are clarified up t the subjects satisfactin and that the ICF is administered by the Investigatr as per the ICH GCP guidelines. These individuals ensure that the enrlled study subjects are infrmed abut their schedule f visits well in advance and that they d nt miss their visits. They cllect and rganize subject data and disseminate the infrmatin t the spnsr n time. Research Pharmacy, Drug Accuntability, and Labratry Respnsibilities The CRC als have t manage the strage f the study drug - accunt fr study drug received frm spnsr, distributed t the patient, returned frm the patient and finally back t the spnsr. They ensure that all labratry specimens such as bld, urine, tissue etc are prperly labeled, packaged and stred befre shipment t the central lab. They even crdinate with the central lab n a regular basis fr the timely receipt f the reprts.

8 Amendments They fllw up with the spnsr fr any amendments in the study prtcl r the ICF and ensure that the amended versins are implemented at the site nly after the favrable written apprval by the IRB. Pst-trial activities Once the hspital phase f the trial is ver, cmpleting the study dcumentatin will becme the key fcus 3. They d a final check f the case reprt frms (CRFs), maintain an archival inventry f recrds and CRFs in a secure place and crdinate the clse ut visits. The jb f the CRC invlves a wide range f activities. They manage the research study the study startup, regulatry activities, and the data. They versee the daily peratins f the trial including handling the finances and cmmunicating with the investigatrs and the spnsrs. As they gain experience they may als assist with the budget preparatin and preparatin f prpsals and essential dcuments. And they finally ascend the hierarchal ladder t the pst f a Team Lead r even a Prject Manager the steps t these successes are multi tasking, prfessinalism, sincerity and hard wrk. 3 Lenble, Eveline. Nurses in Clinical Trials. Nursing BC. Feb FindArticles.cm. 27 Nv