GCDMP Lifetime Maintenance Plan

HISTORY OF SCDM AND GCDMP

The Society for Clinical Data Management is a non-profit professional organization founded in 1994 to promote Clinical Data Management (CDM) Excellence. The Society has over 1300 members from the US and Canada including members from the pharmaceutical, biotech, CRO, device companies, regulatory agencies and academic arenas. The purpose of the SCDM is to advance the discipline of Clinical Data Management as a profession, support educational opportunities to improve skills and specialized knowledge for the discipline of Clinical Data Management, advance professionalism within the discipline of Clinical Data Management by providing an environment for exchange of information and experience, enhance communication among professional groups involved with Clinical Data Management, and to promote standards of good practice within Clinical Data Management.

In alignment with this purpose and recognizing that there were no published good clinical practice guidelines specific to the discipline of Clinical Data Management, the SCDM Board of Trustees established a Committee to develop and publish standards for Good Clinical Data Management Practices in 1998. Versions 1.0, 2.0 and 3.0 of the Good Clinical Data Management Practices guidelines, released to the membership in September 2000, February 2002 and September 2003 respectively, represented a collaborative effort of more than 75 people, with review and input from both members and non-members. Version 1.0 was reviewed by the Data Management Biomedical (DMB), France's Clinical Data Managers association, and their comments were incorporated into Version 3. Prior to the release of version 3, the document was copyrighted. A Lifetime Maintenance Plan (LMP) is being developed to ensure that the continued availability and currency of the document will be implemented.

The GCDMP document is written to serve the needs of multiple audiences who make decisions regarding or using clinical trial data and to provide guidance on accepted practices for the many areas of Clinical Data Management (CDM) that are not covered by existing regulations and guidance documents.

PURPOSE

As is inherently implied in the name, the Lifetime Maintenance Plan is intended to document the details of the process by which the SCDM GCDMP document will be maintained. This plan will allow for a formal review process of the document's sections, incorporate feedback from the readers and users (e.g. SCDM Certification feedback) and the international group International Network of Clinical Data Management Associations (INCDMA). The LMP will allow the introduction of new sections as well as providing for the incorporation of modifications needed or required due to changes in technology or industry regulations. The LMP Subcommittee of the GCDMP Committee will coordinate with the Comments Reviewing, Review and Update, and New Sections Subcommittees to ensure that the LMP is appropriately implemented and is also in line with the efforts of those subcommittees. The LMP subcommittee was created to define the LMP and set policies for the maintenance of the GCDMP document.

The LMP defines the procedures for handling comments and issues identified by the general community. In addition, the LMP addresses how to handle feedback arising from the SCDM certification committee and from those who have become certified, as well as and GCDMP subcommittees' recommendations from ongoing reviews.

The LMP will remain a work-in-progress and will be updated as needed by the GCDMP committee based on feedback received from the CDM community, GCDMP committee members and approved by the SCDM Board of Trustees (BoT). The LMP encourages the users of the GCDMP to make suggestions for document improvements or enhancements to the GCDMP committee.

POLICY

The SCDM is committed to updating the GCDMP in a timely manner as new information becomes available. The updates may be in the form of new sections that are added to the document, removal of sections from the implemented version of the document, and changes to existing sections of the document. The magnitude of the changes generally will indicate whether a new GCDMP version or an amendment number is needed. At a minimum, addition of new sections, deletion of implemented sections, updates to sections as a result of government regulation changes, or any changes to the minimum standards of a section will require a new version number. In addition, new concepts or significant context changes may prompt a change in version number.

Editorial changes, minor changes to best practices, and additions of up to two new best practices will prompt an amendment and will be indicated by a change in the version number suffix (e.g., version 3 changed to version 3.1).

The GCDMP Chief Editor will make the final determination on whether a change is requires a new version or an amendment.

With the release of GCDMP version 3, the document is considered to be final. To maintain a document that is current and of maximum value to CDM professionals worldwide, the GCDMP as a whole will be reviewed at least every two years by the appropriate GCDMP subcommittee (see below for subcommittee responsibilities) to determine if sections need updating. This review will occur on a rotating basis such that at least one section will be reviewed during every fiscal quarter of each year.

Subcommittees
There are four subcommittees, the responsibilities of which are detailed below. The general responsibilities of the subcommittees include holding teleconferences within the subcommittee, coordinating with the other subcommittees, and sharing meeting minutes with the GCDMP committee.

• LMP Subcommittee: this subcommittee will host teleconferences with representative(s) of the following three subcommittees on a quarterly basis: 1) Comments Reviewing, 2) Review and Update, and 3) New Sections. The goal of the teleconference is to assess what sections need to be added, updated, or deleted as indicated by feedback received and/or changes in industry regulation.
  
  
• Comments Reviewing Subcommittee: this subcommittee is responsible for reviewing comments received from various sources such as regulatory agencies, SCDM Certification tests/users, SCDM website, international community, and word of mouth. The Comments Reviewing subcommittee will review the comments at least twice a year, or more often if needed, and make recommendations to the GCDMP committee as to which comments should be incorporated into the GCDMP. The Comments Reviewing subcommittee will provide feedback to those who have submitted comments whenever possible.
  
  
• Review and Update Subcommittee: this subcommittee is responsible for performing a high level review of the GCDMP document at least every two years. It is the intent of the subcommittee to perform an in-depth review of at least 4 sections per year or as deemed necessary by the GCDMP committee. The goal of the review is to determine if any sections should be updated, such as for best practices or new SOPs, and to determine how and where to incorporate comments recommended from the Comments Reviewing subcommittee and approved by the GCDMP committee. When the Review and Update subcommittee agrees that a section should be updated, this information will be shared with the GCDMP committee.
  
  With each new release (new version or amended version) of the GCDMP, a separate document that summarizes the review of and changes to the GCDMP will be prepared by the author(s) and coordinated by the Review and Update subcommittee. The Chief Editor will submit the document to SCDM's management organization for posting on the SCDM website and incorporation into the appropriate SCDM publications (e.g., newsletters). The published document should also mention what sections will be reviewed in the future.
  
  
• New Sections Subcommittee: this subcommittee is responsible for managing and reviewing new sections. Anyone interested in authoring a new section should coordinate with this subcommittee. It is required that the Assignment of Copyright and Limited License Agreement signature be obtained prior to writing the new section. The New Sections subcommittee should continue to require authors to obtain peer review whenever possible before submitting a new section for subcommittee review. When the new sections are ready, the GCDMP committee will review them.

Implementation Process
The GCDMP committee will be given the opportunity to review each updated or new section and to determine if a section should be deleted. Comments should be sent to the author within the specified timeframe or during a full GCDMP committee teleconference. The BoT liaison will then forward the sections for review to the BoT and the INCDMA liaison, along with a summary template for comments. If necessary, the BoT liaison will also schedule a meeting, most likely via a teleconference call, between the BoT and the author(s) or representative committee members or both to discuss the new or updated sections. The sections should be reviewed and agreed upon by the BoT and International Committee within three months. If the BoT members cannot reach consensus on the sections being reviewed, they should bring the items in question back to the full GCDMP committee for discussion and/or revision. It is recommended that the INCDMA organizations send a summary document (e.g., Excel spreadsheet) that includes their comments to the INCDMA liaison, who will then consolidate their comments and forward to the BoT liaison, who will forward the comments to the Chief Editor. The GCDMP committee will discuss the feedback and decide whether and how to incorporate the comments. A spreadsheet of the final changes from the BoT and INCDMA will be prepared by the Chief Editor and forwarded to the BoT for review and final agreement within one month of the receipt of the comments from the BoT and INCDMA. Feedback as to why comments from the INCDMA were not incorporated into the GCDMP section(s) will be summarized by the Chief Editor, who will forward to the BoT liaison. The BoT liaison will forward this information to the INCDMA liaison for distribution to the INCDMA.

The BoT will review the final comments and either approve or return further comments to the GCDMP committee within one month of receipt. After the BoT approves the section(s), the Chief Editor will submit the section(s) to SCDM's management organization for posting on the SCDM website. The separate document that summarizes the review of and changes to the GCDMP will be posted at the same time as well as forwarded to the editors of the SCDM newsletters (Data Basics and SCDM Data Connections).

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