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
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 | |
QRS | |
| MRC | |
| SDS | |
| CDISC foundational standards | |
| Global Governance Group (GGG) | |
| CDISC JIRA issue tracker |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
| Role | Responsibilities |
|---|---|
| CDISC Education Representative | 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 | Creates and maintain on-line and classroom courses. Oversee the qualification of new instructors. Helps identify instructors to teach specific courses |
| CDISC IT | Sets Up standard space in the wiki. |
| QRS Representative. | 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 | 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 | 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) | Receives, reviews, gives feedback and approve modeling examples. |
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 project team. |
| 2.0 | 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. |
| 3.0 | Project Team | If a published clinical outcome assessment is within scope of the project, the team should follow the CDISC QRS process. This process includes reviews of applicable questionnaires and scales used and initiates the process for collecting the required copyright permissions. |
| 3.1 | QRS Representative / Clinical Expert | 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. |
| 4.0 | CDISC IT | Sets up standard space in the wiki |
| 5.0 | 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. |
| 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. |
| 6.0 | Project Manager | Submit concept maps to MRC for Approval |
| 7.0 | Clinical Expert and other Clinical SMEs | Checks 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. This review limited to the team members, SMEs, FDA and other identified stakeholders. Metadata Developers Forum and Concept Modelers Forum
|
| 8.0 | Project Manager | Calls 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. |
General Workflow
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References
List references pertinent to this Work Instruction, e.g., COP-001.