DYNAMIC REFERENCES {Dynamic references are documents that are relevant to clinical data management activities but are not considered part of the CDMP; they are stored separately. The reasons that these documents are separate from the CDMP are threefold. First, the dynamic references may require individuals other than the CDMP primary signatory to approve them, when approval is required. Second, they may be updated on a frequent basis, which would create an unnecessary administrative burden for the CDMP signatories. Third, they may have a document owner that is someone other than the project data manager. This section should discuss the above issues as they pertain to this study and the external documents listed in Table 1. Table 1 should list the full set of dynamic references to be created for this study, including a description of their content and the local storage location of the item. Some items may be handled differently than listed (e.g., some may be combined). Customize the list to the needs of the study. Not all dynamic references will be prepared at the time of the initial CDMP signing. If the dynamic reference is expected, include it in the list below and create a placeholder file in the local storage location indicating that it is not yet available and the approximate time it is expected to be prepared along with the study title of the document owner (e.g., project manager).} Table 1. Dynamic References Current Version Document Storage Location Item Content Owner at DCC Study Contact List Names, roles, and contact Project lead {E.g., the study information for key sponsor website, the and DCC study team communication members plan (including network location)} Annotated Case The full set of CRFs, Project data Report Form including dataset and manager variable names, sorted in protocol schedule order Data Dictionary List of dataset names. List of Project data variable names, with manager corresponding valid values, data types, labels. Data Validation Plan Univariate ranges, Project data description of each electronic manager edit check and custom function edit check, and any additional manual checks that will be performed
DYNAMIC REFERENCES {Dynamic references are documents that are relevant to clinical data management activities but are not considered part of the CDMP; they are stored separately. The reasons that these documents are separate from the CDMP are threefold. First, the dynamic references may require individuals other than the CDMP primary signatory to approve them, when approval is required. Second, they may be updated on a frequent basis, which would create an unnecessary administrative burden for the CDMP signatories. Third, they may have a document owner that is someone other than the project data manager. This section should discuss the above issues as they pertain to this study and the external documents listed in Table 1. Table 1 should list the full set of dynamic references to be created for this study, including a description of their content and the local storage location of the item. Some items may be handled differently than listed (e.g., some may be combined). Customize the list to the needs of the study. Not all dynamic references will be prepared at the time of the initial CDMP signing. If the dynamic reference is expected, include it in the list below and create a placeholder file in the local storage location indicating that it is not yet available and the approximate time it is expected to be prepared along with the study title of the document owner (e.g., project manager).} Table 1. Dynamic References Item Content Document Owner Current Version Storage Location at DCC Study Contact List Names, roles, and contact information for key sponsor and DCC study team members Project lead {E.g., the study website, the communication plan (including network location)} Annotated Case Report Form The full set of CRFs, including dataset and variable names, sorted in protocol schedule order Project data manager Data Dictionary List of dataset names. List of variable names, with corresponding valid values, data types, labels. Project data manager Data Validation Plan Univariate ranges, description of each electronic edit check and custom function edit check, and any additional manual checks that will be performed Project data manager