What are source documents in research?
Source Documents: • Original documents, data and records or certified copies of original records of clinical findings, and observations. Examples: • Signed informed consent forms.
When can a CRF be used as a source document?
With Sponsor approval, study personnel may use Case report forms (CRFs) as source documents if they represent data collected for the study and are where data were initially recorded.
What is CDM in clinical research?
Abstract. Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.
What is study documentation?
How a research study has been set-up, managed, conducted and reported should be able to be reconstructed (at any time point during or after the study) from the documentation that is filed for that study.
What is source document and examples?
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.
What are examples of source documents?
Some examples of source documents include:
- Bank Statements.
- Payroll Reports.
- Invoices.
- Leases & Contracts.
- Check Registers.
- Purchase Orders.
- Deposit Slips – not included on a bank statement.
- Check Copies – not included on a bank statement.
What is a CRF in clinical trials?
A case report form (CRF) is a printed, optical, or electronic document designed to record all protocol-required information on each subject in a clinical research study.
Why are paper forms considered as source documents?
The source document is a good internal control and provides evidence a transaction occurred. Providing source documents to your bookkeeper or accountant in a timely manner assists them in preparation of financial statements and accurately analyzing your business activity.
Which is an example of a source document?
Source Documents: •Original documents, data and records or certified copies of original records of clinical findings, and observations. Examples: •Signed informed consent forms •Hospital records •Clinical charts •Laboratory reports 5 Source Documents Source Documents Source documents are:
Where do eSource documents and data come from?
•eSource documents and eSource data can come from a variety of activities and places. •A list of all authorized data originators should be developed and maintained by the sponsor and site. Data originators entering source data can be: Persons Systems Devices Instruments
Why are clinical trial source documents so important?
Clinical Trial Source documents are the roadmap and clinical record to let me (or anyone who is reviewing) know what happened, when, how, and by whom. When I look through source documents I am checking that they follow the principle of ALCOA:
Where can I find documents for my research?
Scrapbooks and photo albums can also furnish documentary material for research purposes. These types of documents are found in libraries, newspaper archives, historical society offices, and organisational or institutional files.