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It is significantly important to identify and describe the variables that must be included in any data transfer, regardless of where the data originate or the information contained within the data transfer. The purpose of these variables is to merge the external data to the sponsor’s clinical database; safeguard the blind; and ensure that data belonging to a particular protocol, investigator, and subject cannot be loaded to a subject enrolled into a different protocol or to an incorrect visit. Working with the end goal in mind, one can observe that these data may constitute an integral part of the dataset domains proposed by FDA/CDISC for submission:
Dataset | Description |
|---|---|
DEMO | Demographics and subject characteristics |
DISPOSIT | Disposition |
EXPOSURE | Drug exposure |
AE | Adverse events |
CONMEDS | Concomitant medications |
CHEM | Labs – chemistry |
HEMA T | Labs – hematology |
URINE | Labs – urinalysis |
ECG | Electrocardiogram |
VITAL | Vital signs |
PE | Physical examination |
MEDHIST | Past medical history |
Refer to CDISC for additional information.
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- Definition of key variable and mandatory fields
- Data editing and verification procedures
- Record formatting and file formats (e.g. SAS®, ASCII)
- Data transmission
- Database updates
- Data storage and archiving
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While these variables are intended to uniquely identify and clarify subject visit records, incomplete data collection or presentation of errors in either primary or secondary key variables can result in inadequate information. Therefore, completeness in the choice of variables collected and transferred offers a way to increase the accuracy and overall quality of
the process. Primary (protocol subject identifiers) and secondary (additional subject and unique vendor identifiers) key variables can include the following:
Primary Key Variables (Protocol subject identifiers) | Secondary Key Variables (Additional subject and vendor identifiers) |
|---|---|
Sponsor Name / ID | Subject’s Gender |
Study / Protocol ID (any combination of project and protocol) | Subject’s Date of Birth |
Site / Investigator ID | Subject’s Initials |
Subject Identifier (Subject Number, Screening Number or number assigned by the CRF used) | Transmission Date / Time |
Clinical Event ID (Visit Number) | Date associated with the Subject visit |
Sample ID (vendor or device specific sample identifier or a subject visit) | Sequence Number (when more than one observation per record exists) |
Data acquisition forms, whether conventional or electronic (i.e., CRF, e-CRF), should be designed to facilitate the full and accurate reporting of key information at the study site.
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SOPs should be established for, but not limited to, the following:
Sponsor (CRO) | External Data Provider (Vendor) |
|---|---|
External Data Loading and V alidation | Data Extraction and Validation |
Query Generation and Vendor (remote) Database updates | Data Transfer and Discrepancy Handling |
Vendor Auditing | Database Updates |
Database lock procedures | Database Archiving and Security |
Study-specific procedures (including the handling of extra/unscheduled data) | Study-specific procedures (including the handling of extra/unscheduled data) |