RE: SDC-1802 Partnership25 Oct 2025 14:26
A discontinued CRO study would have available data on the trial's design, protocol, and administrative information, such as study status, participant demographics, and recruitment details. While participant-level data on efficacy or safety might be incomplete depending on the point of discontinuation, a complete record of all data collected up to that point, along with case report forms (CRFs), source documents, and reports, would exist.
Trial design and administrative data
Trial registration and status: Registration number, title, date of registration, and the overall status (stopped/completed).
Protocol and study plan: The full protocol document and any amendments, the data management plan, edit check specifications, and CRF completion guidelines.
Participant information: Demographics (age group, gender), inclusion criteria, and target number of participants.
Logistical information: Funder name, ethics approval information, study design (phase, setting, type), start and end dates, countries of recruitment, and the reason for abandonment, if applicable.
Contact and sponsor information: Contact person for the study, sponsor type, and the organization running the trial.
Participant data
Case Report Forms (CRFs): The forms used to collect data on individual participants during the study.
Source documents: Medical records, charts, notes, and other documents that provide the source data for the CRFs.
Collected data: All data points that were collected from participants before the study was stopped, including vital signs, lab results, and any other protocol-defined measurements.
Demographic and baseline information: Critical data for describing the target population and grouping subjects for analysis.
Confidential participant information: All confidential information disclosed during the trial, which would be managed according to the study's legal agreements.
Study conduct and results
Discontinuation reason: The specific reason why the study was discontinued.
Trial status and outcomes: The trial's current status and, if available, any findings or conclusions from the data collected to date, often summarized in a Clinical Trial Report.
Safety data: All safety data collected, as well as any specific data requested by a Data Monitoring Committee.
Data reconciliation and cleaning logs: Documentation of how discrepancies between different data sources were resolved.
Data retention and transfer
Data retention periods: Data must be retained for a specific period, even after a study is discontinued, as required by law and regulations.
Database transfer: If the study is transferred to a new CRO, the existing database will be transferred along with it, allowing the new CRO to access all the data that was collected.
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