What are source documents in clinical trials?
Common source documents are participant medical records, phone encounters or notes, lab and diagnostic test results, participant diaries and specific research worksheets used to document key research data elements. If data are entered directly into a computer system, the electronic record is considered the source.
When can a CRF be used as a source document?
Case report forms (CRFs) may be used as source documents if data will be initially recorded on the form and the intended use is prospectively stated in the protocol; however, it should not be general practice for all data collected during a clinical trial.
Can an eCRF be a source document?
example, an electronic health record system or to a service provider’s database, then the EHR or the service provider’s database is the source. Data elements can be transcribed into the eCRF from paper or electronic source documents.
How do you create a source document for a clinical trial?
3 Tips to Create Outstanding Clinical Trial Source Documents
- 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 does CRF mean in clinical trials?
case report form
A case report form (CRF) is designed to collect the patient data in a clinical trial; its development represents a significant part of the clinical trial and can affect study success. Site personnel capture the subject’s data on the CRF, which is collected during their participation in a clinical trial.
What are considered source documents?
In the accounting industry, source documents include receipts, bills, invoices, statements, checks – i.e., anything that documents a transaction. Any time a business spends or receives money, a source document is created. Source documents are an integral part of the accounting and bookkeeping process.
Why are paper forms considered as source documents?
A source document is an original record which contains the detail that supports or substantiates a transaction that will be (or has been) entered in an accounting system. In the past, source documents were printed on paper. Today, the source documents may be an electronic record.
Which data reported on the CRF should be consistent with the source documents?
The data on the CRF or in the database must be consistent with the original record. Note that medical or other records are independent of the study and may therefore lack precision, detail, documental consistency and completeness as required by the study CRF.
What does CSR mean in clinical trials?
Clinical Study Report
A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related to the study.
What does TLF mean in clinical trials?
Tables, listings, and figures
What is a TLF? Tables, listings, and figures are what are used when writing the Clinical Study Report (CSR), publishing results on ClinicalTrials.Gov, and developing the package insert for approved products.