What are considered source documents in clinical trials?
Source documentation is the medical record of the subject before, during and after the trial. It is the tool which confirms the eligibility criteria of the subject in the given trial. It documents the progress of the subject from consenting till the subject completes the study.
What are the essential documents for a clinical trial study?
The essential documents for clinical trials are the following:
- Investigator’s Brochure.
- Clinical Study Protocol.
- Subject Information and Informed Consent Form.
- Clinical Study Reports.
- Case Report Form (CRF)
Is CRF a source document?
As the CRF is the first place that the data are recorded, the CRF is also considered source data. Note that data items collected directly for the purpose of the study (e.g. diary cards, participant-completed questionnaires) are also considered part of the CRF.
What are the essential documents?
Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.
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 are the regulatory Documents?
Regulatory Documents means all dossiers, filings, applications, modifications, amendments, supplements, revisions, reports, submissions, authorizations and approvals, including any IND or NDA, and any reports or amendments necessary to maintain Regulatory Approvals.
What are study Documents?
Study Documents means all Source Documents and Study Data, and to the extent not included in Source Documents or Study Data, all records, accounts, CRF, notes, reports, data and IEC/IRB communications (submission, approval and progress reports) related to, collected or generated or used in connection with the Study and …
What is Alcoa in clinical research?
Whether they’re recorded on paper or electronically, source data should follow ALCOA: an acronym used in clinical research standing for attributable, legible, contemporaneous, original and accurate.
What are regulatory documents?
Regulatory Documents means all dossiers, filings, applications, modifications, amendments, supplements, revisions, reports, submissions, authorizations and approvals, including any IND or NDA, and any reports or amendments necessary to maintain Regulatory Approvals. Sample 2.
What does source mean in a clinical trial?
Source means originality. Source documents are original documents, data, or records that are created during a clinical study trial. Source documents are essential documents that are required by regulatory and GCP guidelines.
What kind of documents are used in clinical trials?
Documents which are considered as Source Documentation: 1 Informed Consent Forms 2 Medical History 3 Subject Diary 4 Outpatient Medical Chart 5 Various Logs / Hospital Charts 6 Laboratory, MRI or any other reports 7 Hospital records 8 Clinical and office charts 9 Laboratory notes 10 Subjects’ diaries or evaluation checklists
What is the medical record of a clinical trial?
Record of accountability of the investigational product dispensed, consumed and returned during a clinical trial. It is the complete medical record of the subject as the reference to the trail investigators at any point of time.
What does FDA guidance mean for clinical trials?
Guidance documents accessible from this page represent the Agency’s current thinking on the conduct of clinical trials/good clinical practice (GCP) and human subject protection (HSP). The term ‘guidance’ includes documents issued as ‘FDA information sheets.’