Purpose
The purpose of the Public Review is to develop widespread consensus for the proposed standard by allowing for broad comment by the general public.
Scope
The deliverables for Stage 3b are the standards document posting package, including electronic metadata as appropriate.
Prerequisites
- Concept maps for key clinical concepts
- Metadata displays
- SDTM, CDASH and ADaM models or examples, as appropriate
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 |
|---|---|
| SDTM | Study Data Tabulation Model. Provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. |
| CDASH | Clinical Data Acquisition Standards Harmonization. Establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM). |
| ADaM | Analysis Data Model. ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial statistical analyses, an traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM). |
| SRC | |
| SHARE | |
| GGG (Global Governance Group) | 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. |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
| Role | Responsibilities |
|---|---|
| Project Manager | |
| CDISC IT | Posts draft standard package for public review (New Term Request Spreadsheet). |
| Copy Editor | Performs a quality check of draft standards prior to submission to GGG for approval to post for publication. |
| GGG | Reviews and approves all draft standards. Reviews responses to Public Review comments. Reviews and approved any normative content changes. |
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 | Works with the Education Team to schedule a public webinar to coincide with the commencement of the public review period. The purpose of this webinar is to announce the Public Review and help ensure an adequate number of comments are received. |
| 1.1 | Project Manager | Notifies the Education Team of the planned public review posting dates and verifies that the presentation slides are developed. |
| 1.2 | Education Team | Records the webinar to be used as a resource for developing training material. |
| 2.0 | CDISC IT | Posts draft standard package for public review (New Term Request Spreadsheet). |
| 3.0 | Project Manager | Responds to Public Review comments and update the draft document |
| 3.1 | GGG | Reviews responses to Public Review comments. |
| 4.0 | Project Manager | Creates a list of issues for V2. |
| 5.0 | Project Manager | Submits draft standard posting package to publication committee. |
| 5.1 | GGG | Reviews and approved any normative content changes. |
| 5.2 | Project Manager | Submits additional terminology requests and complete other required activities as necessary (QRS). |
| 5.3 | Project Manager | Sends final document to copy editor for review. |
| 5.4 | Copy Editor | Performs a quality check of draft standards prior to submission to GGG for approval to post for publication |
| 6.0 | Project Manager | Submits provisional/final version with resolved comments to SRC. |
| 7.0 | Project Manager | Resolves issues noted by SRC. |
| 8.0 | SRC | Reviews and approves package for public release. |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
References
List references pertinent to this Work Instruction, e.g., COP-001.