<p> Regulatory File Checklist for NCI National Clinical Trials Network (NCTN) Program Trials * denotes items also applicable to non-clinical research</p><p>Background: The Clinical Trials Monitoring Branch (CTMB) of the NCI maintains oversight responsibility for the Network Groups and cancer center CCOP/NCORP auditing programs. The complete federal document can be found on the NCI/CTEP website (http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm). The CTMB Guidelines may be referenced for any policies and procedures that are not specified within the Institutional Audits Policy.</p><p>NCI Network Group trials, such as Alliance and NRG, are audited every 36 months to ensure compliance with CTMB policies and also the Network Group’s standard operating procedures, applicable regulatory requirements, and good clinical practices (GCP). There are 3 components to these audits: IRB Documentation/Informed Consent Content, Pharmacy, and Patient Case Review. </p><p>The regulatory documents maintained for NCTN Network Group trials, and the format in which they are kept, must be in compliance with CTMB policies and audit guidelines. Per CTMB audit guidelines each participating site must maintain a regulatory binder*. In some cases, CTMB requirements may differ from the current DF/HCC Research SOPs; therefore, the structure, format, and types of regulatory files may diverge from DF/HCC standard practices. </p><p>Please use the below information as a reference when creating a regulatory binder for your site as well as when auditing/monitoring regulatory documents for NCTN Network Group trials.</p><p> Trial master files maintained by the DF/PCC NCTN office will be made available to sites using the CIRB/DFCI IRB at the time of audit at the main member site. The trial master files of new protocols submitted after 7/1/2014 are available to all DF/HCC sites via Livelink Secure. DF/HCC sites do not need to maintain a separate regulatory file for the purposes of audits. However, each site will maintain any original delegation of authority logs or other original, site specific documents. A folder for each participating DF/HCC site will be in the trial master file for any site specific documents. Sites should be familiar with how to access Livelink Secure and be able to navigate an auditor through the files. Sites should also reference the NCTN E-Regulatory Management Plan in Livelink Secure for further details regarding location of files.</p><p>Protocol Current IRB approved protocol and all previously approved versions</p><p>Informed Consent Current IRB approved informed consent document(s) and all previously approved versions </p><p>IRB /SRC Review Documents Approval/notification of Scientific Review </p><p>Version: updated July 2016; August 13, 2015 Documentation of full initial protocol approval OR initial Facilitated Review by the local IRB if using the NCI CIRN under the Facilitated Review Model</p><p>Documentation of IRB annual renewals OR Continuing review approvals from the NCI CIRB if using the NCI CIRB under the Facilitated Review Model</p><p>Documentation of IRB submissions/approvals (or disapprovals) of Network Group amendments (addenda and updates) within 90 days of the Group’s notification OR amendment approvals from the NCI CIRB if using the NCI CIRB under the Facilitated Review Model</p><p>Notification of Activation for all DF/HCC and DF/PCC sites </p><p>Documentation of IRB submissions and approvals for local amendments such as approved recruitment materials and educational materials/additional information distributed to subjects (e.g. drug diary) </p><p>Deviation/Violation Tracking Protocol deviations/exceptions/violations tracking log per institutional requirement.</p><p>SAEs/Unanticipated Local reportable SAEs and unanticipated problems (Other Events) reported Problems per the protocol and to the IRB per local policy.</p><p>Sponsor correspondence and IRB review outcome notifications regarding SAEs or unanticipated problems</p><p>General Correspondence Copies of significant communications with Sponsor for all DF/HCC and DF/PCC sites </p><p>Delegation of Authority Delegation of Authority Log per institutional requirement </p><p>Training Initial protocol-specific training records (e.g. Site Initiation Visit (SIV) documentation) per institutional requirement </p><p>Ongoing protocol-specific training records for all DF/HCC and DF/PCC sites </p><p>Version: updated July 2016; August 13, 2015 Screening / Enrollment Enrollment Log (collect from all DF/HCC and DF/PCC sites at time of continuing review) </p><p>Investigator Most recent version of Investigator Brochure or Device Manual and all Brochure/Device Manual previous versions</p><p>IND Safety Reports All serious adverse event (SAE) or unanticipated problems as defined by OHRP policy (see OHRP guidance http://www.hhs.gov/ohrp/policy/advevntguid.pdf) including external safety reports (must be reported to the IRB within 90 days of the Group’s notification or per local policy)</p><p>Overall PI’s determination as to whether each IND Safety Report warrants IRB review</p><p>IND Safety Report submissions to IRB and IRB notifications </p><p>Supervisory Plan Signed and dated Supervisory Plan Summary Form and any updates </p><p>All correspondence supporting the Overall PI’s supervision and oversight activities </p><p>Version: updated July 2016; August 13, 2015</p>