What is source document in clinical trial?
Source Data is defined as all information in original records and certified copies of original records of clinical findings, observations, or other activities (in a clinical investigation) used for the reconstruction and evaluation of the trial.
Source data are contained in source documents (original records or certified copies)'. This means that there are various types of data that are classed as source data. For example: Information which the investigator writes down in the patient's record.
Source document verification (SDV)—the comparison of reported trial data with information from primary health records of trial subjects—is an important component of trial monitoring intended to ensure the integrity of trial data.
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The most common documents are:
- Checks.
- Invoices.
- Receipts.
- Credit memos.
- Employee time cards.
- Deposit slips.
- Purchase orders.
ICH GCP 1.52 defines Source Documents as "Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subject diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after ...
Source documents are so named because they are the original records that prove that a specific transaction took place. The ability of source documents to verify that a specific transaction occurred is exactly what makes them so important.
- Lockbox Check Images. Lockbox check images support the recordation of cash receipts from customers.
- Packing Slip. A packing slip describes the items shipped to a customer, and so supports the recordation of a sale transaction.
- Sales Order. ...
- Supplier Invoice. ...
- Time Card.
What Does Source Document Mean? Some common examples of source documents include sales receipts, checks, purchase orders, invoices, bank statements, and payroll reports. These are all original documents that were created from a transaction and the first component in an accounting system.
Examples of source documents are cancelled checks, credit memos, deposit slips, expense reports, invoices, material requisition forms, purchase orders, time cards, and sales receipts.
- Clinical Trial Participant Inclusion and Exclusion Criteria in your Source Documents. ...
- Use Study Endpoints in Your Source Documents. ...
- Don't Forget Appendices & Tables in Your Clinical Trial Source.
What is source document in CDM?
Definition of the Source Document A source document is a document in which data collected for a clinical trial is first recorded. These data are usually later entered in the Case Report Form.
