Purpose
The purpose of this stage is to develop an approach for meeting the initial requirements and define in more detail the information that will comprise the proposed new or enhanced standard, including comparisons to existing standards.
Scope
Concept Modeling should be used as an opportunity for cross-project review of modeling approaches, to minimize inconsistencies.
Prerequisites
The deliverable for Stage 1 is a list of biomedical concepts, and other relevant artifacts, such as concept maps or terminology requests.
Prerequisites
Requirements assessment, project charter and the scoping package.Indicates if any pre-requisite(s) prior to carrying out this Work Instruction. Put "Not applicable." if this section is not applicable.
Definitions
List terms (abbreviations, acronyms, technical jargon) referenced in this Work Instruction useful at adding clarity. Put "Not applicable." if this section is not applicable.
| Term | Definition |
|---|
| TLC Review Team | Technical Leadership Committee The TLC is made up of Foundational Standards Team Leads. This committee discusses issues pertaining to the Foundational Standards. The TLC also develops the agenda for CDISC IntraChanges and typically leads sessions during these events. |
QRS | Questionnaires, Ratings and Scales. |
| MRC | Medical Research Council. |
| SDS | Submission Domain Standard. |
| CDISC foundational standards | CDISC Foundational Standards are the basis for the complete CDISC suite of standards, supporting the clinical and non-clinical research process from protocol through data collection, data exchange, data management, data analysis and reporting. These standards focus on the core principles for defining research data standards applicable to most research studies, and include models, domains and specifications for data representation. |
| Global Governance Group (GGG) | Responsible for reviewing and approving all draft standards. This group is composed of representatives from each of the foundational teams who have been empowered to review and approve modeling decisions on behalf of their team. The GGG meetings are open to any CDISC team member. |
| CDISC JIRA issue tracker | Jira is a software created by Atlassian for tracking bugs and issues. It is used by the CDISC Library Support Technician ("Support Technician") and the Azure Active Directory Administrator ("Azure Admin") to track CDISC Library accounts. |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
| Role | Responsibilities |
|---|
| Project Manager | - Leads one or more TA projects
- Manages projects by coordinating sub-teams, schedules and deliverables according to the 10-12 month development timeline
- Ensures effective team interactions and overall project communication
- Collaborates with Education Representative to develop TA education materials, or assigns a TA team member, and coordinates team review of draft and final training materials
- Sign up for the GGG review using GGG Signup sheet.
- Assembles project team
|
| CDISC Education Representative | A member of the Education Team - Coordinates development of draft and final training materials with Project Managers
- Orients the Project Team to the Education Team training development process and Presentation Templates
- Facilitates the production and recording of webinars
- Conducts an initial meeting to orient the Project Manager and team on training development procedures and templates.
- Supports the foundational education sub-team leads with process, tools and templates.
|
| Foundational education sub-team leads | A member of the Foundational Standards team - Creates and maintains on-line and classroom courses
- Oversees the qualification of new instructors
- Helps identify instructors to teach specific courses.
- Creates and maintain on-line and classroom courses.
- Oversee the qualification of new instructors. Helps identify instructors to teach specific courses
|
| CDISC ITTechnical Writer | Sets Up standard space in the wiki. |
| QRS Representative. | - Performs inputs process, checking existing Questionnaires, Rating and Scales Supplements
- Reviews initial list of inputs produced with the team
- Ensures questionnaires are mapped to SDTM
- Works with Terminology Team to develop needed new terms
- Develops QRS supplements, as appropriate
- Checks copyright restrictions and resolves them, if possible
- Expands the initial gap analysis, identifies questionnaires that are needed and initiates the process for acquiring permissions
. - Reviews the list of instruments with the Clinical Expert and identifies those that need development
.
|
| Clinical TA Expert | - Functions as the Subject Matter Expert (SME) for therapeutic area concepts, clinical endpoints and terminology
- Facilitates consolidation of clinical data elements and terms
- Responsible for the medical content of TA User Guides by writing, and sometimes reviewing sections of data standards that require clinical expertise, with the Medical Writer
- Reviews and assists in the search of medical literature and regulatory guidance to ensure appropriate references are included, cited and followed, as needed
- Ensures examples in the TA guide are appropriate and clinically accurate, ensures the draft standard is understandable for the implementation community
- Assists team as needed to resolve comments
- Collaborates on the development and review of TA education materials to ensure accuracy and completeness
- Assists with the communication between regulatory experts and project manager
. - Reviews internal clinical check of concepts and concept maps
. The purpose of the review is to ensure the core concepts under development are adequate and appropriate, and that there are no significant concepts missing. - . .
|
| SDTM Expert | - Reviews the output of the initial scoping and planning stage and identifies potential areas that will require new constructs in SDTM
- Completes the gap analysis on SDTM mappings
- Ensures proposed standards are aligned with SDTM
- Collaborates on the development and review of TA education materials to ensure accuracy and completeness, as needed
SDTM Expert- Works with the Project Team to address areas not covered by the current SDTMIG
. It is crucial that the SDTM Expert is included in this process and works closely with the SDS team.
|
| Global Governance Group (GGG) | - Reviews and approves standards prior to posting for internal review, public review and publication
- Ensures that all public review comments have been adequately addressed
- Reviews modeling issues that have been escalated for resolution from internal CDISC teams
- Receives, reviews, gives feedback and approve modeling examples
. - Approves the modeling before the team can move to Stage 2
|
Instructions
Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verb in the Instructions column.
| Step # | Role | Instructions |
|---|
| 1.0 | Project Manager |
Project Manager Assemble Assembles project team |
| 2.0 | CDISC Education Team | Assigns an Education Representative to work with the project team. |
2| 3.0 | Education Representative | The Education Representative conducts an initial meeting to orient the Project Manager and team on training development procedures and templates. |
Chapter 1 (overview) will be developed during this stage. The education team will schedule additional meetings with the Project Manager as needed. As the project team identifies and develops key clinical concepts, the Project Manager compiles a list of important concepts, use cases and examples for inclusion in training materials. |
| 3.1 | Foundational education sub-team leads | Collaborates with CDISC education team for their respective foundational standards |
| 4 |
3If a published clinical outcome assessment is within scope of the project, the team should follow the CDISC QRS process. This process includes reviews | Reviews of applicable questionnaires and scales used and initiates the process for collecting the required copyright permissions. |
3 / Clinical Expert | Expands the initial gap analysis, identifies questionnaires that are needed and initiates the process for acquiring permissions. |
| 4.2 | QRS Representative / Clinical Expert | Reviews the list of instruments |
with the Clinical Expert | and identifies those that need development. |
4CDISC IT| Technical Writer | Sets up standard space in the wiki |
5.0 | | . |
| 6.0 | Metadata Developer | Models Concepts |
| 6.1 | Metadata Developer (Concept Developer) | Defines any concepts that have not been addressed in current CDISC standards to reach a common understanding with the Clinical Expert. |
| 7.0 | Clinical Expert |
Project Manager | Evaluates new and different research concepts |
with the assistance of the Clinical Expert | to ensure the data are clearly understood. |
Performs check of concepts with targeted CDISC community. Concept maps illustrating relationships among the data are developed to facilitate this process. |
| 8.0 | Metadata Developer | Creates concept maps |
| 9.0 | SDTM Expert / SDS Team |
5.1 | SDTM Expert | Works with the Project Team to address areas not covered by the current SDTMIG |
. It is crucial that the SDTM Expert is included in this process and works closely with the SDS team Any issues that cannot be resolved for the first version of the standard must be placed on the SDS issues list so that resolution can be addressed in a later version.6Project Manager | Submit concept maps to MRC for Approval | 7 and other Checks concepts and concept maps. The purpose of the review is to ensure the | Ensures the core concepts under development are adequate and appropriate, and that there are no significant concepts missing |
. This review limited to the team members, SMEs, FDA and other identified stakeholders.| . |
| 12.0 | Project Team | Refines the concept maps and list of concepts as necessary. |
| 13.0 | Project Manager | Submits all examples to the Global Governance Group (GGG) for approval. |
| 13.1 | Project Team | Refines the examples based on GGG feedback. |
| 14.0 | GGG (Global Governance Group) | Approves the modeling before the team can move to stage 2 |
| 15 |
Metadata Developers Forum and Concept Modelers Forum
- Teams are expected to take any examples about which they have questions to the appropriate forum.
- Results of discussions at the forum should be recorded in the forum’s Wiki space. Documentation must include rationales for decisions and labels, including label for the project (e.g., which TA).
- Terminology decisions are currently documented on Terminology pages within the Wiki TA projects and in Terminology team spreadsheets in the portal
8Calls for a CDISC project review with CDISC Project Management and Experts. During the project review, the charter, status of key deliverables, modeling issues, terminology, risks, project plan and next steps may be discussed. The project review occurs at the end of stage 1 to avoid potential delays to the project timeline| Updates the project plan and project charter, and notifies all parties involved. Performs CDISC project review. |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
References
List references pertinent to this Work Instruction, e.g., COP-001.
