University of California, San Francisco Helen Diller Family Comprehensive Cancer Center Policy and Procedure. PRMS Amendment Submission Policy

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1 University of California, San Francisco Helen Diller Family Comprehensive Cancer Center Policy and Procedure PRMS Amendment Submission Policy PRMS Procedure for Submitting Protocol Amendments to the Protocol Review Committee Purpose Per the CCSG Guidelines, it is particularly important for Centers involved in clinical research to establish a mechanism for assuring adequate internal oversight of the conduct of all cancer clinical trials in the institution or institutions that formally comprise the Center. The focus of the Protocol Review and Monitoring System (PRMS) is on scientific merit, priorities and progress of the clinical research in the Center. At UCSF PRMS functions are carried out by the Disease Site Committees and the Protocol Review Committee (PRC). All protocols initially requiring PRC approval must have all amendments reviewed by the PRC. The purpose of this policy is to document the process by which all protocol amendments must be submitted to the PRC for review. The portion of this policy pertaining to institutional (investigator-initiated) clinical trials is modeled after the CTEP Amendment Request Submission Policy, Version date May 14, 2004; it has been modified to meet institutional standards. Procedures What Needs to be Submitted Once a protocol is approved by the PRC, all future changes to that protocol are termed amendments and must be reviewed by the PRC. Amendments are any changes made to the protocol version which was originally approved by the PRC over the life of the clinical trial, regardless of the nature of the change (e.g., editorial, administrative, scientific, etc.). Protocols exempt from PRC review do not require amendment review by the PRC. PRMS Amend. Submission Policy Page 1 of 6 Revision 3 03/19/2014

2 for Industry and National Group Protocols All industry and national group (cooperative group) protocol amendment applications must contain the following documents: A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Disease Site Committee Chair or Co-Chair (required on all protocol amendment submissions). The Summary of s provided by the sponsor, identifying the changes made to the protocol document. An unmarked copy of the revised protocol document which accurately reflects all changes detailed in the Summary of s document. The revised protocol document must contain all appendices listed in the Table of Contents, regardless of whether or not they were revised. Exception: if case report forms (CRFs) are identified in the Table of Contents those CRFs do not need to be included, unless the amendment affects the CRFs. for Investigator-Initiated Protocols from Outside Institutions All protocol amendment applications for multicenter investigator-initiated trials for which UCSF is a participating institution and not the coordinating center must contain the following documents: A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Disease Site Committee Chair or Co-Chair (required on all protocol amendment submissions). The Summary of s provided by the outside institution (the sponsorinvestigator), identifying the changes made to the protocol document. If the outside institution does not supply a Summary of s, the UCSF Helen Diller Family Comprehensive Cancer Center template must be used (see for UCSF Institutional (Investigator-Initiated) Protocols below). An unmarked copy of the revised protocol document which accurately reflects all changes detailed in the Summary of s document. The revised protocol document must contain all appendices listed in the Table of Contents, regardless of whether or not they were revised. Exception: if case report forms (CRFs) are identified in the Table of Contents those CRFs do not need to be included, unless the amendment affects the CRFs. PRMS Amend. Submission Policy Page 2 of 6 Revision 3 03/19/2014

3 for UCSF Institutional (Investigator-Initiated) Protocols All protocol amendment applications for UCSF institutional (investigator-initiated) trials (those created by a UCSF investigator) must contain the following documents: A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Disease Site Committee Chair or Co-Chair (required on all protocol amendment submissions). A Summary of s which identifies each change made to the protocol document. Each change must be described in a point-by-point format which identifies the page number, section number, specific changes, and a brief rationale for the change where appropriate (e.g., Page 5, Section 1.3, original text = abc, replacement text = xyz, rationale for change). Page numbers should reflect the clean unmarked copy of the protocol document. (See suggested template: Amendment Submissions - Summary of s Template, The Summary of s must include the current protocol title, protocol number, and the revised version date and version number (see protocol document discussion below). An unmarked copy of the revised protocol document which accurately reflects all changes detailed in the Summary of s document. The revised protocol document must contain all of the following: All appendices listed in the Table of Contents, regardless of whether or not they were revised. Exception: if case report forms (CRFs) are identified in the Table of Contents those CRFs do not need to be included, unless the amendment affects the CRFs. The version date must be revised. The revised version date will be a single date on which all changes were made to the protocol document. Note: There is no requirement for the dating of individual editorial or administrative updates within the body of the protocol. Rather, it will be the policy of this institution that all changes made to a specific protocol (i.e., all changes listed on the Summary of s document) are understood to have been made at the same time, that is, on the same, single date reflected in the version date. Any changes occurring after that timepoint need to be included in another, future, amendment submission. The protocol document title page must include a history of all version dates (and version numbers if applicable), beginning with the first official version number and date to have undergone any formal regulatory review (e.g.: Version 1.0 = mm/dd/yyyy; Version 2.0 = mm/dd/yyyy; etc.). See the Phase I and Phase II ITR Protocol Templates for examples, PRMS Amend. Submission Policy Page 3 of 6 Revision 3 03/19/2014

4 The header or footer on each page must reflect the revised version date (and version number if applicable). Not required: Use of a version number in conjunction with the required version date is highly recommended, but not required. However, if not currently using version numbers on a previously approved protocol, do not begin to use version numbers with an amendment. If version numbers have been in use from the inception of the project, then the version number must be revised with each amendment. The recommended method of version numbering will be to use 1.0 as the initial version number (the approved Final version, i.e., the first non-draft version). Using this recommended method, all amendments would therefore have a version number greater than 1.0. Suggested method is to use whole numbers for all amendments (e.g., 2.0, 3.0, etc.). An alternate method would be to use whole numbers for major amendments (e.g., 2.0, 3.0, etc.), and decimal numbers for minor amendments (e.g., 1.1, 1.2, etc.). Should version numbers be used, the method selected must be used consistently throughout the life of the protocol. If the amendment is in response to a request for revision from a collaborator, the FDA, CHR, or any other regulatory body, a copy of that request for revision document should be included. How to Submit All amendments must be submitted within OnCore (the Cancer Center s secure electronic web-based database) per the directions found in the PRC (eprms) User Manual (see ittee%20(prc)%20in%20oncore.aspx). Incomplete Applications Incomplete applications will not be reviewed. Responding to Contingent Approval of an Amendment The PI s response to Contingent approval of an amendment application must follow the criteria outlined in above, but need only include those documents that were revised in response to the Contingent approval status. The only exception to this is that all Contingent approval response submissions must include a separate document that discusses each concern point-by-point and explains how each was addressed. This document should be modeled on the Amendment Submissions - Summary of s Template, I.e., it should identify the page number, section number, specific changes, and a brief rationale for the change where appropriate (e.g., Page 5, Section 1.3, original text = abc, replacement text = xyz, rationale for change). If a requested change is not made, the summary of changes should provide a rationale for not doing so. Page numbers should reflect the clean unmarked copy of the protocol document. PRMS Amend. Submission Policy Page 4 of 6 Revision 3 03/19/2014

5 Withdrawal Procedure An amendment may be withdrawn by the PI or designee while it is still in the review process. If an amendment has been approved by PRC, but not by any other regulatory body (other than Disease Site Committee), the approval may be withdrawn. The request for withdrawal must be made in writing. If an amendment has been approved by any regulatory body other than PRC or a Disease Site Committee it cannot be withdrawn. Should the PI wish to reverse an amendment that cannot be withdrawn, the PI must submit a new amendment application as in above, reversing the amended items. Alternate Procedures There are no alternate procedures to this policy. PRMS Amend. Submission Policy Page 5 of 6 Revision 3 03/19/2014

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7 University of California, San Francisco Helen Diller Family Comprehensive Cancer Center Policy Revision Summary of s Policy Title: 0BPRMS Amendment Submission Policy Version Date: March 19, 2014 Version Number: Revision 3 Notes: Page number corresponds to page number in updated version (Revision 3). New text in modified paragraphs is shown as bold italics and deleted text is shown as strikethrough. Page No.: All pages Section: Footer Revision 2 03/09/11 New Text Revision 23 03/0919/20114 Updated text to reflect revised version number and date. Page No.: 1 New Text Section: Sub-Title PRMS Procedure for Submitting Institutional Protocol Amendments to the Protocol Review Committee PRMS Procedure for Submitting Institutional Protocol Amendments to the Protocol Review Committee Updated text to correctly reflect content: Industry and National Group protocols are also addressed. Page No.: 1 Section: Purpose Per the CCSG Guidelines, it is particularly important for Centers involved in clinical research to establish a mechanism for assuring adequate internal oversight of the conduct of all cancer clinical trials in the institution or institutions that formally comprise the Center. The focus of the Protocol Review and Monitoring System (PRMS) is on scientific merit, priorities and progress of the clinical research in the Center. At UCSF PRMS functions are carried out by the Program Site Committees and the Protocol Review Committee (PRC). All protocols initially requiring Protocol Review Committee (PRC) approval must have all amendments reviewed by the PRC. PRMS Amend. Submission Policy Page 1 of 7 Version Date: 03/19/2014 Summary of s Version Number: Revision 3

8 New Text Page No.: 1 Per the CCSG Guidelines, it is particularly important for Centers involved in clinical research to establish a mechanism for assuring adequate internal oversight of the conduct of all cancer clinical trials in the institution or institutions that formally comprise the Center. The focus of the Protocol Review and Monitoring System (PRMS) is on scientific merit, priorities and progress of the clinical research in the Center. At UCSF PRMS functions are carried out by the Program Disease Site Committees and the Protocol Review Committee (PRC). All protocols initially requiring Protocol Review Committee (PRC) approval must have all amendments reviewed by the PRC. Updated text to reflect the new name for site committees, and editorial change. Section: Purpose New Text The purpose of this policy is to document the process by which all protocol amendments must be submitted to the Protocol Review Committee for review. The portion of this policy pertaining to institutional (investigatorinitiated) clinical trials is modeled after the CTEP Amendment Request Submission Policy, Version date May 14, 2004; it has been modified to meet institutional standards. The purpose of this policy is to document the process by which all protocol amendments must be submitted to the Protocol Review CommitteePRC for review. The portion of this policy pertaining to institutional (investigatorinitiated) clinical trials is modeled after the CTEP Amendment Request Submission Policy, Version date May 14, 2004; it has been modified to meet institutional standards. Editorial change. Page No.: 2 Industry and National Group for Industry and Cooperative Group Protocols All industry and cooperative group protocol amendment applications must contain the following documents: A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Site Committee Chair or Co-Chair (required on all protocol amendment submissions). PRMS Amend. Submission Policy Page 2 of 7 Version Date: 03/19/2014 Summary of s Version Number: Revision 3

9 New Text for Industry and CooperativeNational Group Protocols All industry and national group (cooperative group) protocol amendment applications must contain the following documents: A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Disease Site Committee Chair or Co-Chair (required on all protocol amendment submissions). Text revised to reflect new NCI term for cooperative group trials, and to reflect the complete name for the Disease Site Committees. Page No.: 2 Investigator-Initiated, Outside Institutions A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Site Committee Chair or Co-Chair (required on all protocol amendment submissions). New Text A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Disease Site Committee Chair or Co-Chair (required on all protocol amendment submissions). Text revised to reflect the complete name for the Disease Site Committees. Page No.: 3 UCSF Investigator-Initiated A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Site Committee Chair or Co-Chair (required on all protocol amendment submissions). New Text A PRC Amendment Submission Form signed by the Principal Investigator (PI) and the Disease Site Committee Chair or Co-Chair (required on all protocol amendment submissions). Text revised to reflect the complete name for the Disease Site Committees. Page No.: 3 UCSF Investigator-Initiated PRMS Amend. Submission Policy Page 3 of 7 Version Date: 03/19/2014 Summary of s Version Number: Revision 3

10 A Summary of s which identifies each change made to the protocol document. Each change must be described in a point-bypoint format which identifies the page number, section number, specific changes, and a brief rationale for the change where appropriate (e.g., Page 5, Section 1.3, original text = abc, replacement text = xyz, rationale for change). Page numbers should reflect the clean unmarked copy of the protocol document. (See suggested template: PRC Amendment Application - Summary of s) New Text A Summary of s which identifies each change made to the protocol document. Each change must be described in a point-bypoint format which identifies the page number, section number, specific changes, and a brief rationale for the change where appropriate (e.g., Page 5, Section 1.3, original text = abc, replacement text = xyz, rationale for change). Page numbers should reflect the clean unmarked copy of the protocol document. (See suggested template: PRC Amendment Application Submissions - Summary of s Template, Text revised to reflect the correct title and web address of the suggested template for the required Summary of changes document. Page No.: 3 New Text UCSF Investigator-Initiated The protocol document title page must include a history of all version numbers and version dates, beginning with the first official version number and date to have undergone any formal regulatory review (e.g.: Final Version = Version Number 1.0; Amendment Number 1 = Version Number 2.0, etc.). See Sample Protocol Facepage for an example. The protocol document title page must include a history of all version numbers and version dates (and version numbers if applicable), beginning with the first official version number and date to have undergone any formal regulatory review (e.g.: Final Version = Version Number 1.0 = mm/dd/yyyy; Amendment Number 1 = Version Number 2.0, = mm/dd/yyyy; etc.). See the Sample Protocol FacepagePhase I and Phase II ITR Protocol Templates for an examples, Adjusted versioning wording to better denote that version dates are required, but version numbers may be used in addition to dates; and to revise version examples to match current practice within the ITR. d link to take readers to the sample protocol templates contained within the description of the ITR s Institutional Trials Unit (Protocol Development and Regulatory Unit). PRMS Amend. Submission Policy Page 4 of 7 Version Date: 03/19/2014 Summary of s Version Number: Revision 3

11 Page No.: 4 New Text Page No.: 4 New Text UCSF Investigator-Initiated The footer on each page must reflect the revised version date (and version number if applicable). The header or footer on each page must reflect the revised version date (and version number if applicable). Text revised to reflect current practice; sometimes the version information is contained in the document header instead of the footer. UCSF Investigator-Initiated Not required: Use of a version number in conjunction with the required version date is highly recommended, but not required. However, if not currently using version numbers on a previously approved protocol, do not begin to use version numbers with an amendment. If version numbers have been in use from the inception of the project, then the version number must be revised with each amendment. The recommended method of version numbering will be to use 1.0 as the initial version number (the approved Final version, i.e., the first non-draft version). Using this recommended method, all amendments would therefore have a version number greater than 1.0. Suggested method is to use whole numbers for major amendments (e.g., 2.0, 3.0, etc.), and decimal numbers for minor amendments (e.g., 1.1, 1.2, etc.). Should version numbers be used, the method selected must be used consistently throughout the life of the protocol. Not required: Use of a version number in conjunction with the required version date is highly recommended, but not required. However, if not currently using version numbers on a previously approved protocol, do not begin to use version numbers with an amendment. If version numbers have been in use from the inception of the project, then the version number must be revised with each amendment. The recommended method of version numbering will be to use 1.0 as the initial version number (the approved Final version, i.e., the first non-draft version). Using this recommended method, all amendments would therefore have a version number greater than 1.0. Suggested method is to use whole numbers for all amendments (e.g., 2.0, 3.0, etc.). An alternate method would be to use whole numbers for major amendments (e.g., 2.0, 3.0, etc.), and decimal numbers for minor amendments (e.g., 1.1, 1.2, etc.). Should version numbers be used, the method selected must be used consistently throughout the life of the protocol. PRMS Amend. Submission Policy Page 5 of 7 Version Date: 03/19/2014 Summary of s Version Number: Revision 3

12 Text revised to reflect current practice within the ITR. Page No.: 4 New Text Responding to Contingent Approval of An Amendment The PI s response to Contingent approval of an amendment application must follow the criteria outlined in above, but need only include those documents that were revised in response to the Contingent approval status. The only exception to this is that all Contingent approval response submissions must include a separate document that discusses each concern point-by-point and explains how each was addressed. This document should be modeled on the PRC Amendment Application - Summary of s template. I.e., it should identify the page number, section number, specific changes, and a brief rationale for the change where appropriate (e.g., Page 5, Section 1.3, original text = abc, replacement text = xyz, rationale for change). If a requested change is not made, the summary of changes should provide a rationale for not doing so. Page numbers should reflect the clean unmarked copy of the protocol document. The PI s response to Contingent approval of an amendment application must follow the criteria outlined in above, but need only include those documents that were revised in response to the Contingent approval status. The only exception to this is that all Contingent approval response submissions must include a separate document that discusses each concern point-by-point and explains how each was addressed. This document should be modeled on the PRC Amendment Application Submissions - Summary of s ttemplate, I.e., it should identify the page number, section number, specific changes, and a brief rationale for the change where appropriate (e.g., Page 5, Section 1.3, original text = abc, replacement text = xyz, rationale for change). If a requested change is not made, the summary of changes should provide a rationale for not doing so. Page numbers should reflect the clean unmarked copy of the protocol document. Text revised to reflect the correct title and web address of the suggested template for the required Summary of changes document. Page No.: 5 Section: Withdrawal Procedure An amendment may be withdrawn by the PI or designee provided it is still in the review process. The request for withdrawal must be made in writing. Once an amendment has been approved by the PRC it cannot be withdrawn. Should the PI wish to reverse an amendment once it is approved by PRC, the PI must submit a new amendment application as in above, reversing the amended items. PRMS Amend. Submission Policy Page 6 of 7 Version Date: 03/19/2014 Summary of s Version Number: Revision 3

13 New Text Page No.: 6 An amendment may be withdrawn by the PI or designee providedwhile it is still in the review process. If an amendment has been approved by PRC, but not by any other regulatory body (other than Disease Site Committee), the approval may be withdrawn. The request for withdrawal must be made in writing. OnceIf an amendment has been approved by any regulatory body other than the PRC or a Disease Site Committee the PRC it cannot be withdrawn. Should the PI wish to reverse an amendment that cannot be withdrawnonce it is approved by PRC, the PI must submit a new amendment application as in above, reversing the amended items. Updated withdrawal section to allow for pulling an approved amendment if it has not been approved by any other regulatory bodies other than the HDFCCC PRC and Disease Site Committees. Section: Policy Approval Judith Luce, MD Date Chair, Protocol Review Committee New Text Judith LuceAndrew Ko, MD Date Chair, Protocol Review Committee in leadership. PRMS Amend. Submission Policy Page 7 of 7 Version Date: 03/19/2014 Summary of s Version Number: Revision 3