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13 NN PM 503 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR STUDY MATERIALS DEVELOPMENT SOP: NN PM 503 Version No.: 2.0 Effective Date: 21Oct2016 STUDY MATERIALS DEVELOPMENT Supercedes Document: Version 1.0 Effective Date: 06May POLICY For all studies approved to be conducted within the NeuroNEXT Network, the Clinical Coordinating Center (CCC) will work with the Data Coordinating Center (DCC) and the Protocol Principal Investigator (PPI) or his/her designee to develop study-specific templates and other materials to be used by Clinical Study Sites (CSS) in the conduct of study-related activities. The CCC and DCC will collaborate to develop additional Network templates and materials that are used across NeuroNEXT studies, as needed. Study materials are posted to the internal study website and are accessible to all authorized NeuroNEXT personnel. The following sections present examples of study materials that are typically developed for each NeuroNEXT study. Manual of Operations (i.e. Manual of Procedures; MOP) A MOP is a study-specific, version-controlled document that describes study processes and procedures. A MOP is developed for every NeuroNEXT study, and is used as a reference and a training tool for instructing CSS personnel on study conduct. The study MOP incorporates an organizational plan that defines responsibilities, a study roster that contains contact information for the Study Team, and a communications plan that provides contact information for specific members of the Study Team who are directly involved with study management. The MOP also includes a training plan, information on study logistics and procedures, a plan for recruitment and retention, and study enrollment procedures. Instructions related to protocol compliance, study medications, concomitant and prohibited medications, safety reporting, outcome measures, data collection and management, study closeout, and confidentiality and publication are also typically included in the study MOP. The MOP also may also describe laboratory procedures, including directions for processing and shipping laboratory specimens and directions for ordering/re-ordering study supplies and investigational product, as applicable. The PPI, appropriate CCC and DCC personnel, and a representative from the Sponsor Company (if applicable) sign off on the study MOP and any subsequent revisions or amendments. Other Study-Specific Materials The following study-specific materials may be developed for use in a study (as applicable): Data collection templates and related materials o o o o Source documents Data entry templates CRF forms grid Assessment instruments (e.g. questionnaires, quizzes) Study-specific guidance documents, training manuals and materials, or user s manuals, such as: o o o Website and data entry user s manuals Imaging manual and shipping instructions Educational materials (e.g., videos, slide presentations) NN PM 503 Page 2 of 5

14 o o Laboratory manuals Specimen processing and tracking manual Temperature logs for freezers Pharmacy manuals Site pharmacy manual Study medication administration instructions Study drug dispensing system user s manual Study drug accountability log Network Templates and Materials 2. SCOPE Standard Operating Procedures (SOPs) Study staff Delegation of Responsibilities (DOR) log template Addition of study staff form Study staff certification form Note to File template Data Change Request (DCR) form template This SOP has been developed to be in alignment with federal regulations and Good Clinical Practices (GCP) as set forth in the 1996 ICH E6 Consolidated Guidance. The policies and procedures described in this SOP apply to the NeuroNEXT CCC and DCC within the context of their oversight and advisory roles for the NeuroNEXT Network, and to all NeuroNEXT investigators, staff, subcontractors, or other entities associated with the NeuroNEXT Network who manage, oversee, and conduct research regulated by FDA and/or applicable review committees. 3. ROLES AND RESPONSIBILITIES The CCC, DCC, and PPI or his/her designee are responsible for developing a study-specific materials such as a MOP, source documents, and other materials and tools that may assist CSS in the conduct of the study. The CCC and DCC are responsible for developing Network-wide templates and materials, when needed. 4. APPLICABLE REGULATIONS AND GUIDELINES 21 CFR General Responsibilities of Sponsors ICH E6 The Principles of ICH GCP 5. REFERENCES TO OTHER APPLICABLE SOPS NN GA ATTACHMENTS AND REFERENCES NN PM 502 A Document Development and Change Control Document History 7. TERMS AND ABBREVIATIONS The following terms and abbreviations are used in this document: CCC CSS Clinical Coordinating Center at Massachusetts General Hospital Clinical Study Site NN PM 503 Page 3 of 5

15 DCC FDA ICH MOP PPI Data Coordinating Center at The University of Iowa U.S. Food and Drug Administration International Council for Harmonisation Manual of Operations (i.e. Manual of Procedures) Protocol Principal Investigator 8. SPECIFIC PROCEDURES A. Manual of Operations (MOP) # Who Task Attachment / References Related SOP 1. CCC, DCC, and PPI or designee 2. PPI and applicable CCC and DCC personnel; Sponsor Company representative (if applicable) Draft a Manual of Operations (MOP) that describes study processes, procedures, and responsibilities of the CCC, DCC, study management personnel, and other key study personnel (if applicable). NN GA 103 Sign off on the final version of the MOP. NN GA CCC, DCC Provide each participating CSS access to the MOP on the internal study website. 4. PPI and applicable CCC and DCC personnel; Sponsor Company representative (if applicable) Revise the MOP as necessary, and re-sign the revised version. NN GA CCC, DCC Provide each participating CSS access to the updated/amended MOP. B. Other Study Materials # Who Task Attachment / References Related SOP 1. CCC, DCC, and PPI or designee Develop study-specific materials and tools as deemed appropriate for each study. NN GA CCC, DCC Provide each participating CSS access to study materials and tools on the internal study website. 3. CCC, DCC, and PPI or designee Revise study materials and tools, as needed. NN GA CCC, DCC Provide each participating CSS access to updated study materials and tools on the internal study website, as needed. NN PM 503 Page 4 of 5

16 Attachment NN PM A. Document History NeuroNEXT Network Standard Operating Procedure (SOP) Study Materials Development SOP NN PM 503 Version Description of Modification Reason or Justification for Modification Issue Date Effective Date 1.0 New N/A 06Apr May Extensively revised to include a description of the study Manual of Operations (i.e. Manual of Procedures; MOP), and listings of other study-specific and Network materials that may be developed to assist CSS with proper study conduct. Removed references to a study manual for CSS. Updates for version Sep Oct2016 NN PM 503 Page 5 of 5

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18 NN PM 504 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR INVESTIGATIONAL SITE STAFF TRAINING SOP: NN PM 504 Version No.: 2.0 Effective Date: 21Oct2016 INVESTIGATIONAL SITE STAFF TRAINING Supercedes Document: Version 1.0 Effective Date : 06May POLICY For all NeuroNEXT Network studies, each participating Clinical Study Site (CSS) will undergo ongoing staff training on: all aspects of the study protocol; scientific rationale for the study; management of anticipated adverse events applicable to the Investigational Product; adverse event management; principles of Good Clinical Practice (GCP); and other study-related topics, as determined by the CCC, the DCC, and the PPI (or designee). Each CSS will undergo re-training as needed throughout the course of a clinical investigation. New site staff members that join study participation after initial CSS training has occurred will be trained before they are permitted to engage in any study-related tasks. The CCC and DCC will maintain records of CSS trainings / certifications. 2. SCOPE This SOP has been developed to be in alignment with federal regulations and Good Clinical Practices (GCP) as set forth in the 1996 ICH E6 Consolidated Guidance. The policies and procedures described in this SOP apply to the NeuroNEXT Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC) within the context of their oversight and advisory roles for the NeuroNEXT Network, and to all NeuroNEXT investigators, staff, subcontractors, or other entities associated with the NeuroNEXT Network who manage, oversee, and conduct research regulated by FDA and/or applicable review committees. 3. ROLES AND RESPONSIBILITIES The NeuroNEXT CCC and DCC are responsible for verifying that each participating CSS site meets all applicable requirements for facilities, personnel, Good Clinical Practices (GCP) compliance, and regulatory compliance prior to initiation of the clinical investigation at that site, and maintaining records of trainings/certifications. The CCC is responsible for issuing a written notification of CSS activation once all required study start-up training and documentation is completed for a CSS participating in a given study. The CCC is also responsible for forwarding the notification of Central Institutional Review Board (CIRB) approval/activation and approved Informed Consent Forms to the CSS. The CCC and DCC are responsible for ensuring that all site personnel who will participate in the conduct of the clinical investigation have completed a protocol training session prior to the initiation of that site staff member s participation in the clinical investigation. The DCC is responsible for ensuring that all site personnel who perform data entry into the electronic data entry system have completed Data Entry Certification prior to the initiation of data entry activities. The CCC and DCC are responsible for reviewing the qualifications of site personnel who will be performing specified clinical research procedures, and for verifying the training of site personnel in these procedures prior to certification of the CSS and before any staff member begins newly delegated tasks. NN PM 504 Page 2 of 5

19 The CCC and DCC are responsible for confirming, prior to CSS certification, that any laboratories at participating sites that perform laboratory processing or point-of-care testing for the clinical investigation are compliant with Good Laboratory Practices and institutional guidelines. The CCC, in collaboration with the DCC and the PPI as needed, is responsible for creating and providing appropriate study materials and checklists to aid in conduct of a clinical investigation to all CSS. The CCC is responsible for informing the Protocol Principal Investigator (PPI) of any participating CSS investigator who has failed to maintain appropriate licensure or certification requirements, as specified in applicable regulations. When appropriate (or as requested by the PPI), the CCC and the DCC are responsible for providing CSS training and retraining on the following areas using an appropriate training medium: protocol compliance; clinical research procedures; adherence to GCP; and regulatory requirements. 4. APPLICABLE REGULATIONS AND GUIDELINES ICH E6, 5.5 ICH E6, 5.15 ICH E6, 8.0 Trial Management, Data Handling and Record Keeping Record Access Essential Documents for the Conduct of a Clinical Trial 5. REFERENCES TO OTHER APPLICABLE SOPS NN RA 202 NN RA 203 NN SS 402 NN SS 403 NN SS 404 NN SS 405 NN PM 503 NN DM 1005 Trial Master File Maintenance Site Regulatory File Maintenance Site Initiation Visits and Site Training Routine Monitoring Visits Site Performance Monitoring Study Closeout Visits Study Materials Development Data Collection and Data Handling 6. ATTACHMENTS AND REFERENCES NN PM 504 A Document History 7. TERMS AND ABBREVIATIONS The following terms and abbreviations are used in this document: CAPA CCC CSS DCC FDA GCP ICH Corrective Action and Preventative Action plan Clinical Coordinating Center at Massachusetts General Hospital Clinical Study Site Data Coordinating Center at The University of Iowa U.S. Food and Drug Administration Good Clinical Practice International Council for Harmonisation NN PM 504 Page 3 of 5

20 PPI Protocol Principal Investigator 8. SPECIFIC PROCEDURES A. Site and Personnel Training # Who Task Attachment Related SOP 1. CCC, DCC, and PPI or designee Determine which trainings, certifications, and regulatory requirements are to be met by the participating CSS prior to initiation of the clinical investigation, and throughout the duration of the investigation. NN RA 202 NN SS CCC Confirm that the site has completed training in all applicable GCP guidance documents, clinical and laboratory procedures, data entry procedures, and use of study-related equipment or instrumentation. NN SS 402 NN DM CCC Provide a written notice of approval and activation to each CSS that has completed all required training and site activation activities, along with the notification of CIRB approval/activation and the Informed Consent Form(s). 4. CCC Maintain documentation of CSS and personnel trainings / certifications for each CSS in the study Trial Master File. 5. CSS Maintain documentation of CSS and personnel training in the Site Regulatory Binder. NN RA 202 NN RA 203 B. Ongoing Site and Personnel Training # Who Task Attachment Related SOP 1. CCC, DCC, and PPI or designee Develop requirements for scheduling ongoing trainings for participating CSS. 2. CCC, DCC Provide on-site training or web-based training per schedule or for cause, as warranted. NN SS 402 NN SS CCC, DCC Study Monitor Periodically review any applicable instrumentation maintenance certifications to ensure that they are current. NN SS CCC Review certification-related documents for each participating CSS to ensure that they are accurate and complete. 5. DCC, CCC Report lapses in certifications to the PPI, and follow up with the site to ensure that criteria for certification are re-established, or to initiate procedures for recertification, when necessary. NN SS 403 NN SS DCC, CCC, and PPI or designee If a site demonstrates a need for retraining, work with site personnel and the PPI to create a Corrective Action and Preventative Action (CAPA) plan to rectify any issues and perform retraining. NN SS 404 NN PM 504 Page 4 of 5

21 Attachment NN PM A. Document History NeuroNEXT Network Standard Operating Procedure (SOP) Investigational Site Staff Training SOP NN PM 504 Version Description of Modification Reason or Justification for Modification Issue Date Effective Date 1.0 New N/A 06Apr May Revised to indicate that the CCC is responsible for sending written notification of activation to CSS that have completed all training and site activation requirements, along with the CIRB approval/activation letter and ICFs. The CCC is also responsible for reviewing any certification-related documents for each CSS to ensure that they are accurate and complete. Other minor edits. Update for version Sep Oct2016 NN PM 504 Page 5 of 5

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34 NN PM 507 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR STUDY CLOSEOUT SOP: NN PM 507 Version No.: 1.0 Effective Date: 21Oct2016 STUDY CLOSEOUT Supercedes Document: N/A Effective Date: N/A 1. POLICY This SOP describes site-level and study-level activities that are conducted by the NeuroNEXT Data Coordinating Center (DCC) and Clinical Coordinating Center (CCC), in collaboration with clinical study sites (CSS), during the final closeout of a study. Some of these activities are performed concurrently, and the timeframe for study closeout may vary somewhat depending on the study. Resource requirements for study closeout are considered during the study development phase and many activities that are performed during study closeout (e.g. CSS monitoring, data cleaning, and tracking data completeness) are also ongoing throughout the study. Active planning for study closeout generally begins with the close of enrollment, but planning may begin earlier depending on the nature of the study. Study Team members will collaborate to develop a timeline for closeout activities and to define the roles and responsibilities of team members in the closeout process. As the study progresses, closeout activities will be added to the agendas for Study Team meetings. Activities associated with study closeout visits to CSS, some of which may be conducted by or in collaboration with the CCC, are described in SOP NN SS 405 Study Closeout Visits. If the study or participation of a CSS is being terminated early, follow additional applicable procedures described in SOP NN SS 406 Suspension or Early Termination of a Study or a Clinical Site. The CCC leads activities related to close-out of the Trial Master File and close-out of the Site Regulatory Files at CSS. The DCC leads activities associated with data cleaning and tracking data completeness. These activities continue until the final study data are locked and ready for analysis. Final study data include data that were submitted to the study database through the electronic data capture (EDC) system and any data that were transferred electronically to the DCC from external vendors (e.g. imaging centers or central laboratories, if applicable to a study). Reports, trackers, and other tools are developed and reviewed for each study to track progress of study closeout. Detailed checklists may be developed for each study that contain required site- and study-level closeout procedures for data and other study activities. General closeout activities that are performed at the site and study levels as the study nears completion are described below. Site-level Closeout Site-level closeout refers to a period in which activities are performed by the NeuroNEXT DCC and the CCC in conjunction with individual CSS to ensure that the participating sites are ready for study-level closeout. During this period, the DCC and/or the CCC or Study Team (as applicable) conducts closeout monitoring visits according to the study monitoring plan and SOP NN SS 405, reviews site-level reports and tools to track study closeout progress, resolution of data discrepancies, and data completeness, and ensures that all data are accounted for and any necessary data corrections are complete. Once it is verified that the NN PM 507 Page 2 of 12

35 data for a CSS are ready for final study data lock, data entry rights for the site are removed, and no further changes to study data by CSS personnel are permitted. The CCC leads the review of the Site Regulatory Files that have been uploaded to the Regulatory Document Storage area of the NeuroNEXT study-specific website and verifies with the CSS that all required regulatory documents have been collected, are up-to-date, and have been uploaded to the website. The CCC also works with each CSS, as needed, to verify that the regulatory files are accurate and complete. For additional information and specific procedures related to closeout of study files, data, and regulatory documents at CSS, refer to SOP NN SS 405. The following activities must be completed for each participating CSS before final study closeout: preparing for and conducting onsite or remote study closeout visit(s), and submitting a study closeout monitoring report to the CSS PI, the PPI/Sponsor, and the CCC and/or DCC (if applicable); verifying the contents of the Site Regulatory Files, subject binders, and other study files at the CSS and submitting a regulatory closeout report to the CSS PI, the PPI/Sponsor, and the DCC and/or the CCC (if applicable); verifying the disposition of the investigational product/device, study supplies and equipment, and laboratory specimens (as applicable); collecting the monitoring log, and laboratory specimen tracking and/or investigational product accountability logs (as applicable); tracking issues or data discrepancies that are described in the closeout monitoring report(s) until resolved; verifying that all data queries are resolved and all data corrections are complete; deactivating data entry rights and Query System access at CSS after all closeout procedures are complete and assigning View Only access to applicable site personnel; collecting documentation of CSS PI signoff on study data from CSS; performing reconciliation of invoices and final payments to the CSS; closing out the CSS as a performance site with the CIRB. Study-level Closeout Study-level closeout refers to a period in which the NeuroNEXT DCC and/or the CCC or Study Team (as applicable) review(s) study-level reports and tools to track study closeout progress, resolution of data discrepancies, and data and regulatory document completeness across sites. The DCC leads efforts to verify that all data queries and discrepancies have been resolved and confirms that the study database is ready to be locked. After the study database is locked, no further changes to study data are permitted. After the database has been locked, DCC Biostatisticians perform a final data freeze, create analysis data sets, and conduct statistical analyses as described in the study Statistical Analysis Plan (SAP). Applicable DCC teams collaborate with the PPI/Sponsor and the Study Team or other NeuroNEXT personnel (as needed) to ensure that study data are appropriately de-identified and ready to be shared. Study-level closeout activities conducted by the DCC and/or CCC, in collaboration with CSS or external vendors (as applicable), may include: NN PM 507 Page 3 of 12

36 developing a timeline for study closeout activities, and defining the roles and responsibilities of Study Team members; notifying the Study Team, CSS personnel, the PPI/Sponsor, applicable Committees or review Boards (e.g. Protocol Steering Committee [PSC], NeuroNEXT Data and Safety Monitoring Board [DSMB], study Safety Review Committee), and other applicable personnel (e.g. study Safety Monitor) that study closeout procedures are beginning; coordinating closeout activities with the PPI/Sponsor and any third-party vendors for the study (if applicable); performing activities associated with closeout of the Trial Master File and fulfilling regulatory requirements, in conjunction with the PPI/Sponsor (as applicable); reviewing study-level reports and trackers to ensure that all data closeout activities are complete across all participating CSS; verifying that any data that have been sent from external vendors (e.g. imaging or central laboratory data) have been successfully uploaded and reconciled (if applicable to a study); locking the study database; generating and validating analysis data sets; performing, documenting, and validating statistical analyses; preparing a final study report; and preparing and de-identifying study data for sharing. Please refer to Section 8 of this SOP for additional details and the general sequence of events that occur during the data closeout period. 2. SCOPE This SOP has been developed to be in alignment with federal regulations and Good Clinical Practices (GCP) as set forth in the 1996 ICH E6 Consolidated Guidance. The policies and procedures described in this SOP apply to the NeuroNEXT Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC) within the context of their oversight and advisory roles for the NeuroNEXT Network, and to all NeuroNEXT investigators, staff, subcontractors, or other entities associated with the NeuroNEXT Network who manage, oversee, and conduct research regulated by FDA and/or applicable review committees. 3. ROLES AND RESPONSIBILITIES The NeuroNEXT DCC and/or CCC, in collaboration with the Study Team and vendors (as applicable), are responsible for: conducting a closeout visit at a CSS after the last subject has completed the study and all data entry has been completed; working with CSS (as applicable) to perform all activities related to cleaning and close-out of study data, locking the study database, and conducting statistical analyses according to the study SAP; working with CSS to perform all activities related to close-out of the regulatory files (Trial Master File and Site Regulatory Files) and close-out of the study with the Central Institutional Review Board (CIRB); monitoring the progress of study closeout activities by creating and reviewing reports and trackers; NN PM 507 Page 4 of 12

37 working with the PPI/Sponsor (if applicable), the Study Team, and the CSS as needed to complete site-level and study-level study closeout procedures described in this SOP. 4. APPLICABLE REGULATIONS AND GUIDELINES 21 CFR Review of Ongoing Investigations 21 CFR Disposition of Unused Supply of Investigational Drug 21 CFR General Responsibilities of Investigators 21 CFR Investigator Recordkeeping and Record Retention 21 CFR Investigator Reports 21 CFR Inspection of Investigator's Records and Reports ICH E6, 4.12 ICH E6, 4.13 ICH E6, 5.18 ICH E6, 5.20 ICH E6, 5.21 ICH E6, 5.22 Premature Termination or Suspension of a Trial Final Reports by Investigator Monitoring Noncompliance Premature Termination of a Trial Clinical Trial/Study Reports 5. REFERENCES TO OTHER APPLICABLE SOPS NN GA 105 NN GA 107 NN GA 109 NN RA 201 NN RA 202 NN RA 203 NN RA 206 NN SS 401 NN SS 402 NN SS 403 NN SS 405 NN SS 406 NN PM 501 NN PM 505 NN SM 602 NN CS 704 NN CS 706 NN QA 801 Vendor Selection and Agreements Data Sharing Sharing Data with Industry Collaborators Regulatory Authority Submissions and FDA Contact Trial Master File Maintenance Site Regulatory File Maintenance Medical Monitoring and Safety Monitoring Site Selection and Qualification Site Initiation Visits and Site Training Routine Monitoring Visits Study Closeout Visits Suspension or Early Termination of a Study or a Clinical Site Communication Investigational Product Management Central Institutional Review Board Reporting System Security Measures and Website Access Retention and Protection of Electronic Records Quality Assurance Audits NN PM 507 Page 5 of 12

38 NN BIO 904 NN BIO 905 NN BIO 906 NN DM 1001 NN DM 1005 Generation and Validation of Analysis Data Sets Validating Statistical Programs and Deliverables Presenting Statistical Results for a Final Study Report Clinical Data Management Data Collection and Data Handling 6. ATTACHMENTS AND REFERENCES NN PM 507 A Document History 7. TERMS AND ABBREVIATIONS The following terms and abbreviations are used in this document: AE CCC CIRB CRF CSS DCC DSMB ecrf EDC FDA ICH IRB PPI PSC SAP TMF Adverse Events Clinical Coordinating Center at Massachusetts General Hospital Central Institutional Review Board Case Report Forms that are completed for each study subject at the sites Clinical Study Site Data Coordinating Center at The University of Iowa Data and Safety Monitoring Board Electronic Case Report Form Electronic Data Capture U.S. Food and Drug Administration International Council for Harmonisation Institutional Review Board Protocol Principal Investigator Protocol Steering Committee Statistical Analysis Plan Trial Master File (Regulatory Master File) 8. SPECIFIC PROCEDURES The specific procedures described in this section are organized by closeout activity, and may represent a combination of site-level and study-level tasks. Additional acronyms used in this section: BIO DCC Biostatistics team; DM DCC Data Management team; IT DCC Information Technology team; PC DCC Protocol Coordination team; PM CCC Project Management team; QM Quality Management team. A. Communications and Project Management (Study Level) # Who Task Attachment Related SOP 1. DCC PC and Inform the Study Team, the CSS, the PPI/Sponsor, applicable Committees or review NN RA 206 NN PM 507 Page 6 of 12

39 # Who Task Attachment Related SOP CCC PM Boards (e.g. PSC, NeuroNEXT DSMB, study Safety Review Committee), and other applicable personnel (e.g. study Safety Monitor) that the study closeout process is beginning, and provide updates as needed or requested. 2. Study Team Develop a timeline for study closeout activities and define the roles and responsibilities of Study Team members in the closeout process. 3. Study Team Continue to perform all ongoing data cleaning and quality checks and generate relevant reports throughout the study closeout process and resolve any discrepancies. 4. Study Team Determine the contents of specialized reports (e.g. Study Closeout Report) that are used to track study closeout activities and the frequency of distribution. 5. Study Team Determine which Study Team members will be reviewing all reports that track study closeout activities and who will follow up on unresolved items. NN PM Study Team If study participants are to carry over to an extension or ancillary study, develop a plan for transfer of subject information (if applicable) and for separate collection and handling of data and regulatory documents for the new study. 7. Study Team In the case of early termination of the study (e.g. for unreasonable risks posed by the investigation) or a CSS (e.g. for insufficient enrollment, protocol deviations or other noncompliance, or by request of the site), or by order of the PPI/Sponsor, FDA, the CIRB, or upon recommendation of the NeuroNEXT DSMB, follow procedures described in SOP NN SS 406. NN RA 202 NN RA 203 NN CS 704 NN DM 1005 NN SS 406 B. Regulatory Closeout # Who Task Attachment Related SOP 1. CCC PM or designee Review for completeness and accuracy all regulatory documents that have been uploaded to the Regulatory Document Storage area on the NeuroNEXT Network website, including: essential clinical study documents; site-specific certifications and investigator documentation. NN SS 405 NN PM 507 Page 7 of 12

40 # Who Task Attachment Related SOP 2. CCC PM or designee Confirm that all activities are completed for final closeout of the study with the CIRB. C. Study Closeout Visit and Final Data Corrections (Site Level) NN RA 602 # Who Task Attachment Related SOP 1. DCC PC and/or CCC PM, or designee 2. DCC PC and/or CCC PM, or designee 3. DCC PC and/or CCC PM, or designee 4. DCC PC or designee 5. DCC PC or designee 6. DCC PC or designee Follow up on any issues or missing data that were discovered during the study closeout visit until all are resolved. If a CSS does not complete data corrections or resolve issues after repeated attempts by the DCC and/or CCC (if applicable) to follow up, inform study leadership and escalate the process to involve the PPI/Sponsor or others as needed to complete the closeout for the site. Verify that all outstanding corrections to the site data have been implemented through a postcomplete change or a Data Change Request to the DCC. Verify that all Data Change Request forms are signed and filed according to study requirements. Communicate final resolutions of data corrections to the CSS. Collect documentation of CSS PI signoff on study data for all applicable CSS, if applicable. NN SS 403 NN SS 405 NN SS 405 NN DM 1005 NN DM 1005 NN SS 405 D. Review of CSS Data (Site Level) # Who Task Attachment Related SOP 1. DCC PC, BIO, DM, IT Review reports and perform data quality and completeness checks. 1. Run database queries and data entry edit checks to verify that all are resolved. 2. Run a program to check that all dates within a visit preceded the date of the subsequent visit, and verify that any discrepancies are resolved. 3. Run a program that checks for possible duplicate ecrfs within and across visits, and verify that any discrepancies are resolved. 4. Run all reports related to study closeout to verify that study data are complete and no outstanding data corrections are needed. NN DM 1005 NN PM 507 Page 8 of 12

41 # Who Task Attachment Related SOP 2. DCC PC, BIO, DM, IT If any new or unresolved data issues are discovered, continue to re-run database queries, data entry edit checks, programs, and reports until all issues have been resolved. NN DM Study Team Review trackers related to study closeout to verify that site data are ready to be locked. 4. DCC PC or designee Inform the DCC IT Lead and the Study Team that site data entry rights are ready to be removed. NN PM 501 E. Deactivating Data Entry Rights at a CSS (Site Level) # Who Task Attachment Related SOP 1. DCC IT After all necessary data corrections have been made: 1. Remove data entry rights for CSS personnel. 2. Assign View Only rights to applicable personnel at the CSS. 3. Disable the ability of the CSS to use the Query System. 2. DCC IT Inform the Study Team that the site data are locked from further changes by the CSS and are ready for study-level closeout. NN CS 704 NN PM 501 F. Data Transfers (Study Level) # Who Task Attachment Related SOP DCC PC, BIO, DM, IT DCC PC, BIO, DM, IT If applicable to a study, verify that all expected imaging and/or central laboratory data described in the Data Transfer Agreement(s) were: received; successfully uploaded; checked for missing data, discrepancies, and extreme values; and reconciled and resolved of any issues. Confirm that the final, complete data set was received from the PI and/or the vendor(s). G. Locking the Study Database (Study Level) # Who Task Attachment Related SOP 1. DCC PC and IT Inform the Study Team of the impending database lock. NN PM 501 NN PM 507 Page 9 of 12

42 # Who Task Attachment Related SOP 2. DCC DM Run queries, data entry checks, programs, and reports across all participating CSS to verify that there are no further data discrepancies to be addressed DCC PC and Study Team DCC PC, DM, BIO, IT DCC PC or designee DCC IT and DM DCC IT and DM DCC IT and DM Review study-level reports, trackers, queries, and data entry edit checks to verify that study closeout activities are complete across all participating CSS. If any new or unresolved data issues are discovered, continue to re-run database queries, data entry edit checks, programs, and reports until all issues have been resolved. When all study closeout activities are complete, inform DCC IT, DM, and BIO that the study database is ready to be locked. Verify that data entry rights for all CSS have been removed, View Only status has been assigned for applicable personnel, and Query System access for the sites has been disabled. Ensure that the study data are locked from any further changes. Inform DCC BIO that the final study database has been locked. NN BIO 904 H. Statistical Analyses and Reporting Results (Study Level) # Who Task Attachment Related SOP 1. DCC BIO If required for a study, perform a freeze on a subset of cleaned study data for the purpose of generating a preliminary study report. 2. DCC BIO After all study data have been cleaned, perform a final data freeze on a copy of the locked final database. 3. DCC PC and BIO Generate and submit the final safety report to the Safety Monitor for the study. 4. DCC BIO Generate final analysis data sets that are to be used in statistical analyses that have been described in the SAP for the study. 5. DCC BIO Develop, document, and validate statistical programs for analyses that have been described in the SAP for the study. 6. DCC BIO Present statistical results from the study in a final study report. NN BIO 906 NN BIO 904 NN RA 206 NN BIO 904 NN BIO 905 NN BIO 906 NN PM 507 Page 10 of 12

43 I. Data Sharing (Study Level) # Who Task Attachment Related SOP 1. Study Team Refer to SOPs NN GA 107 Data Sharing and NN GA 109 Sharing Data with Industry Partners for procedures related to sharing final study data with study investigators and the scientific community and sharing de-identified data sets for public use. NN GA 107 NN GA Study Team Review and follow PPI/Sponsor requirements and guidance documents for data sharing. 3. Study Team Within 12 months of LPLV, prepare final results for PPI submission to ClinicalTrials.gov. 4. Study Team Determine the timeframe for the submission of data to the PPI/Sponsor and/or a repository. 5. DCC De-identify raw study data and statistical analysis data sets in accordance with HIPAA requirements. 6. DCC Verify that all potentially identifiable information has been removed or de-identified prior to sharing study data. 7. DCC DM Generate annotated Case Report Forms (CRFs) for sharing. 8. DCC BIO, DM, QM Assemble and submit the required deliverables to the appropriate entities. NN GA 107 NN GA 109 NN GA 107 NN GA 109 NN PM 507 Page 11 of 12

44 Attachment NN PM A. Document History NeuroNEXT Network Standard Operating Procedure (SOP) Study Closeout SOP NN PM 507 Version Description of Modification Reason or Justification for Modification Issue Date Effective Date 1.0 New N/A 21Sep Oct2016 NN PM 507 Page 12 of 12

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