Multi-Site Coordination Process. Drafted by: Ester Dimayuga Page 1 of 18

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1 Multi-Site Coordination Process Drafted by: Ester Dimayuga Page 1 of 18

2 MULTI-SITE COORDIATIO (MSC) REGULATOR PROCESS CTO-Regulatory notifies MSC of trial with UMCC as coordinating center MSC prepares site regulatory packages for sites Site regulatory packages ready to be sent to sites? IRB approval obtained? MSC sends regulatory package to sites Site processing of regulatory documents and contract Wait for IRB approval Local IRB approval obtained? Site contract finalized? MSC reviews documents submitted by site Site sends completed regulatory documents to MSC Questions/Discrepancies identified? MSC coordinates with CTO-IT to grant access to reference materials MSC gives site access to study reference materials MSC maintains site Regulatory file Drafted by: Ester Dimayuga Page 2 of 18

3 Regulatory Documents From MSC to each participating site: Protocol and amendment, if applicable Model Informed Consent Form Protocol Acceptance Form IRB approval letter CI approval letter, if applicable Investigational Brochure, if applicable Safety reports, if applicable Form 1572 Financial Disclosure, if applicable Site contracts (to be provided by Finance, if applicable) Site Study Contact List Drafted by: Ester Dimayuga Page 3 of 18

4 Regulatory Documents (continued) From each participating site to MSC after local IRB approval has been obtained: Signed Protocol Acceptance Form Local IRB approval of protocol/amendment Local informed consent form and local IRB approval letter IRB roster of membership Form 1572 Financial Disclosure of site primary investigator and co-investigator Current curriculum vitae of each study personnel Current medical licenses for primary investigator and co-investigator(s) Current CLIA Laboratory Certificate of Accreditation Current CAP Certification Current lab reference ranges Study contact list with contact information Drafted by: Ester Dimayuga Page 4 of 18

5 MULTI-SITE COORDIATIO (MSC) SITE PRE-IITIATIO PROCESS Regulatory notifies MSC of trial with UMCC as CC Are there other study reference materials from other study team members? Study team member prepares study reference materials MSC prepares study reference materials All study reference materials in Velos? Electronic copy of study reference materials provided to MSC Are the study reference materials final? Site processing of contract Site contract finalized? Local IRB approval obtained? Site processing of regulatory documents MSC coordinates with CTO-IT to grant study database access to site MSC gives site access to study reference materials Drafted by: Ester Dimayuga Page 5 of 18

6 Study Reference Materials From MSC to each participating center: Binder cover and spine AE/SAE Reporting Process Table of Contents CTEP AE Expedited Report, if applicable Contact Information Drug Ordering and Accountability Role of investigator, if applicable Pharmacy Dispensing Guidelines Protocol Data and Safety Monitoring Plan Study Enrollment Procedure Data and Safety Monitoring Report Screening and Enrollment Log otice of Protocol Deviation Delegation of Authority Sheets Specimen Handling Monitoring Visit Log Shipping Instructions and Forms Correspondence Specimen Labels Telephone Contact Report Supply Order Form Velos Data Entry Overview Lab Certifications Velos User Manual Lab ormal Values Patient Status Terminology Drafted by: Ester Dimayuga Page 6 of 18

7 MULTI-SITE COORDIATIO (MSC) STUD DOCUMETS FILIG PROCESS MSC creates or receives study document Is document in electronic format? Document conversion to electronic format Post document in appropriate folder in shared drive Is document a study reference material? Is document in PDF format? Document conversion to PDF format Post document in study database Drafted by: Ester Dimayuga Page 7 of 18

8 MULTI-SITE COORDIATIO (MSC) SITE IITIATIO PROCESS MSC gives site access to study reference materials MSC prepares presentation materials for site initiation Site downloads reference materials and creates study reference binder Presentation materials ready? Training database ready? IT finalizes training database Study reference binder ready? MSC coordinates initiation training with IT and site MSC informs site of date and attendees of training Site confirms date and attendees MSC conducts site initiation training Site faxes Attendance Sheet to MSC; site ready for enrollment MSC issues Site Initiation Visit Report no later than 1 week after completion of site initiation Drafted by: Ester Dimayuga Page 8 of 18

9 Site Initiation Meeting Topics Protocol Study design, requirements and compliance Subject Recruitment Exclusion and inclusion criteria Enrollment process Study Calendar Schedule of study procedures and assessments CRFs Design and completion Data collection and database maintenance Data clarification process, if applicable Source Data/Document Verification Guidelines Drug Supplies Receipt, dispensing, return and accountability Storage requirements, as necessary Drafted by: Ester Dimayuga Page 9 of 18

10 Site Initiation Meeting Topics (continued) Laboratory Logistics Sample collection and shipment AE/SAE Reporting Different required reports Processes and standards GCPs and applicable regulatory requirements Data and Safety Monitoring process and requirements IRB re-approval needs and processes Monitoring Frequency of visits and expectations Preparation for monitoring visits Audits and auditing processes Preparation for a site audit Records management and retention requirements Creation and maintenance of site master files Drafted by: Ester Dimayuga Page 10 of 18

11 Site Initiation Meeting Topics (continued) Issue resolution and communication process flow Review of site contact list and CTO-UMCC study directory Unblinding Process Reasons Required documentation Question and Answer Throughout the entire site initiation, encourage study staff to raise any questions or feedback they might have. It is possible for a question/issue to be unanswered or unresolved by the end of the site initiation. In such a case, assure the site that those would be followed-up on until they have been answered or resolved. Drafted by: Ester Dimayuga Page 11 of 18

12 Site Initiation Participants Recommended Site Participants: Principal investigator The principal investigator must make every effort to attend the site initiation. If not possible, the site s co-investigator should be in attendance. Site staff Study coordinator Study nurse Pharmacist All other study staff identified in the Delegation of Duties and Signature Log Drafted by: Ester Dimayuga Page 12 of 18

13 MULTI-SITE COORDIATIO (MSC) EROLLMET PROCESS Site screens a patient Site documents patient in Screening and Enrollment Log Is patient eligible? Site completes Eligibility Worksheet and obtains PI signature; provides source docs Site updates patient status in log as screen failure UMCC Registrar assigns patient study ID and notifies site of enrollment; logs patient on Master Enrollment Log, files enrollment documents Is documentation sufficient? UMCC Registrar reviews Eligibility Worksheets and source docs Site sends Eligibility Worksheets and source docs to UMCC Registrar Site updates patient status as enrolled; enters enrollment data into database Is there any deviation from protocol? Is protocol deviation first of its kind in the study? MSC forwards case to UM PI for review and approval Site completes otice of Protocol Deviation and obtains PI signature and related documents UM PI approves protocol deviation? MSC notifies site of UM PI decision Site sends Protocol Deviation and supporting documents to MSC Site updates patient status in log as screen failure Drafted by: Ester Dimayuga Page 13 of 18

14 MULTI-SITE COORDIATIO (MSC) SAE REPORTIG PROCESS Site has a reportable SAE Is study sponsored by CI? Site reports to CC: PI, Regulatory and MSC copied Site reports to sponsor, if required by protocol Site reports to local IRB Site reports to CI via AdEERS; PI and MSC copied Site reports to local IRB Site sends MSC copy of IRB s acknowledgement of receipt of SAE report MSC files report in site s Regulatory binder MSC forwards SAE report to CTO Regulatory contact MSC forwards SAE report to other participating sites MSC files report in site s Regulatory binder Regulatory contact notifies IRB via eresearch Drafted by: Ester Dimayuga Page 14 of 18

15 MULTI-SITE COORDIATIO (MSC) EARL CODE RELEASE PROCESS Site pharmacist completes Code Release Form Site investigator approves request for Code Release Site pharmacist sends form, documents/info to MSC MSC reviews paperwork: All information sent? Site pharmacist resolves deficiency MSC notifies site pharmacist of deficiency MSC obtains PI signature on Code Release Form MSC s site pharmacist of code release approval; copies site PI, CC s PI and statistician PI approves site request for early code release MSC notifies PI of site request for approval MSC faxes site a copy of signed Code Release Form Site pharmacist releases treatment code OL to site PI Drafted by: Ester Dimayuga Page 15 of 18

16 DATA AD SAFET MOITORIG PROCESS (only for investigator-initiated multi-site trials with no independent external DSMB) Protocol deviations Adverse events Patient accrual Protocol deviations Site completes Protocol Deviation Form Site completes Protocol Specific Data and Safety Monitoring Report Site submits completed report with pertinent documentation to MSC MSC forwards report and documents to DSMC DSMC provides reports and documents to DSMB - Drafted by: Ester Dimayuga Page 16 of 18

17 MULTI-SITE COORDIATIO (MSC) MOITORIG PROCESS MSC conducts site initiation Site ready for enrollment Site enrolls patients into study Actual visit to the site Telephone conference Investigator s Meeting Site has enrolled 5 patients? Study completed, terminated or cancelled? Site continues to enroll patients into the study MSC conducts monitoring visit; issues Monitoring Visit Report no later than 1 week after completion of visit MSC conducts site close-out MSC issues Close-Out Visit Report no later than 1 week after completion of visit Actual visit to the site Source docs and charts review Actual visit to the site Source docs and charts review Drafted by: Ester Dimayuga Page 17 of 18

18 QUALIT ASSURACE AD AUDIT On-site audit of selected patient records CTO/DSMB requests audit for a study Audit of source documents and research records at CC CI/DOD- sponsored study Investigator-initiated study CI audit of selected patient records at participating site CI audit of source documents and research records at Coordinating Center On-site audit of selected patient records Audit of source documents and research records at CC Site prepares for audit Site sends documents to CTO Site prepares for audit Site sends documents to CTO MSC notifies site of audit Site prepares documents MSC notifies site of audit Site prepares documents MSC notifies site of audit MSC notifies site of audit Drafted by: Ester Dimayuga Page 18 of 18