GIP Working Groups

About GIP Working Groups

Reporting to the TAB is the GIP Architecture Working Group, comprised of LSIT staff and volunteers who are the keepers of the overall GIP roadmap and provide guidance to the practice area working groups. This group also has responsibility for strategic planning (with regard to practices and industry trends), overall project planning, resource development and allocation, documentation standards maintenance, and liaison with standards and practices organizations.

Working Groups are constituted based on the published priority development needs for GIP; there are usually from two to three practice areas either in development or in revision at any given time. Working groups have a structure that consists of a Project Manager or PM Team appointed by LSIT and any number of Subject Matter Experts (SMEs), who elect a Group Leader to represent them and work with the Project Manager to move the project along.

Working Group roles include:

Project Management Roles

Project Management roles are associated with managing the development of Good Informatics Practices. There are two major roles - Project Director and Project Manager. The Project Director works directly for LSIT and takes direction from the Executive Director and the Technical Advisory Council. There would be at least one Project Director for all of GIP, and there could be more. The Project Manager is more executionoriented and most likely is "seconded" to LSIT from a Life Sciences member company.

Project Director

The role of the Project Director is to orchestrate all of the activities associated with GIP development projects. This includes identifying, vetting and assigning resources, distilling direction from the Technical Advisory Council into project outcomes, and defining project budgets, timelines, and deliverables. The project director is responsible for GIP architecture development, updates and changes, GIP information design and workproduct composition, and for ensuring deliverable interoperability (with other practices) and adherence to document standards and quality guidelines.

Project Manager

The role of the project manager is to drive progress on a GIP development project or projects. This includes development of project-specific work plans, task outlines and work descriptions, acquiring resources and assigning work, and tracking / follow-up on tasks and deliverables. The project manager focuses on deliverable timeliness, and on complying with LSIT design and build guidelines.

Project Administrator

As the development activities associated with GIP become more varied and multiple projects get underway, it may be necessary to add a Project Administrator. This individual would be responsible for: maintaining volunteer information, intake and pre-screening of volunteers, creation / updating of MS Project plans, development and production of project management reports, identifying and following up on project variances and production issues, and management of project libraries, documents, work papers and work products.

Working Group Roles

Working Group roles are associated with the actual development of Good Informatics Practices content and deliverables within the context of specific Practice Area Working Groups. There are two major roles within each working group - Working Group Leader (WGL) and Subject Matter Experts (SMEs). The Working Group Leader is the coordinator for the Working Group and coordinates with the Project Manager. Group Leaders may be employees of a member Life Sciences Organization or may be volunteers. Subject Matter Experts provide thought leadership for specific practices and techniques, and may very well come from outside of member organizations, either from vendors or the volunteer ranks. Principal Researchers, Researchers and Contributors are variations on the SME roles, and would be integrated into working groups on an "as needed" basis.

Working Group Leader

The Group Leader is the subject matter expert most responsible for providing thought leadership and guidance to a specific practice development effort. The Group Leader works with the Project Director to identify individual contributors with specific practice knowledge and expertise and to attract these individuals to the GIP development project. Once the practice development process is underway, the group leader provides guidance to the group, focusing on deliverable quality and usefulness of the specific practice to the life sciences industry.

Subject Matter Expert

The Subject Matter Expert (SME) contributes knowledge and expertise in specific informatics practices to the GIP effort. Most SMEs will have specific knowledge of particular practices, and will work within work groups to document practices, policies and procedures, and to provide expertise and consultation to other group members. Most working groups will be comprised of multiple SMEs.

Principal Researcher

Principal Researchers undertake original research into best practices for LSIT. Differing from SMEs, the Researchers' real strength may not lie so much in a deep understanding of current best practices as in the application of tools and techniques for identifying, defining and evaluating new practices as they develop. Researchers may have backgrounds and experience in consulting or technology firms rather than direct experience with pharmaceutical or life sciences IT operations. The Principal Researcher leads specific research into new technologies, techniques, and tools that support a practice area and provides leadership to researchers working for the group. Additionally, should LSIT be able to obtain grant funding for defined best practices research, such grants often stipulate the appointment of a Principal Researcher.

Researcher

Like Principal Researchers, Researchers undertake original research into best practices for LSIT, primarily by assisting the Principal Researcher. Researchers will have more limited backgrounds and expertise aligned with specific technologies. The Researcher will assist in the conduct of specific research into new technologies, techniques, and tools that support a practice area and will provide assistance to the Principal Researcher and to other Researchers working for the group.

Contributor

A contributor plays a contributing role in developing content for a practice. Most often, contributors will be subject matter experts with a specific and narrow expertise, and they may be interviewed by members of the working group, rather than actually documenting their contributions themselves. Anyone who contributes to a practice document should be cited, and the provenance of their contribution noted.

Editorial Roles

One of the design objectives for GIP is that the practice series will be well-written and edited. This will help differentiate the GIP series from the many other methods, practices and standards available today. Therefore, a strong editorial presence, with well-defined roles, is critical to maintain adherence to practice design objectives and style guidelines and to insure readability and coherence of the practice guidelines.

Editor

The GIP Series will need individuals to serve in editorial capacities. Often, Subject Matter Experts and Contributors are so familiar with their subject that they may leave out information that is germane to the implementation of a practice, or assume greater familiarity with specific issues or techniques than is actually the case with the audience. Each practice document will have an editor, and there will be an editorial board on which editors will serve. This board will serve to insure that there is consistency in enforcement of documentation standards, and that workproducts and practice documents have been appropriately reviewed and approved for publication.

Technical Editor

When practice documentation is particularly technical or the subject matter of a GIP publication is particularly dependent on the implementation of one or more specific technologies, the series Editor may choose to assign a Technical Editor to the project. The Technical Editor serves several functions: to insure that the technical content of a practice document is accurate and clearly represented, that explication of and instruction in a technology is appropriately written for the targeted audience, and also that technical information is presented in a way that is neutral with regard to vendors of specific technology solutions. This role will be particularly important to practices that are heavily reliant on vendor or consultant input.

Technical Writer

Often, Subject Matter Expert and other contributors will have great knowledge and expertise in Good Informatics Practices but may not be able to clearly translate that knowledge into practices that can be implemented in other organizations. The Technical Writer assists the GIP working groups and SMEs in translating their practice knowledge into implementable practices. The technical writer will follow published LSIT style guides and insure that practice and technique documentation conforms to guidelines and is easy to understand and interpret.

Proofreader

The Proofreader assists the series Editor and the Working Group to insure that changes are correctly made and reflected in workproducts, and that appropriate version controls are implemented. To this end, the proofreader serves as more than simply a reader of the document or a grammarian - the proofreader will need to have some knowledge of the subject, the ability to understand the meaning of the information communicated, and be able to manage practice documents through the revision cycle.