What are source documents for 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 source documents ICH GCP?

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 …

What is the Good Clinical Practice Network?

GCP. Network closes the gap between research and clinical practice. It is a powerful platform for mental health professionals to participate in international research initiatives and to share new findings and innovative practices in evidence-based clinical care.

What are the five source documents?

What are source documents and why are they important?

• 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 types of source documents?

Examples of source documents, and their related business transactions that appear in the financial records, are:

• Bank statement.
• Cash register tape.
• Credit card receipt.
• Lockbox check images.
• Packing slip.
• Sales order.
• Supplier invoice.
• Time card.

Which chapter of ICH GCP is essential documents listed?

At the core of these are the essential documents, as defined by ICH Guideline for Good Clinical Practice, E6, Section 8, “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.”

How do you certify a copy in clinical research?

A process should be in place to certify that the electronic copy is an accurate representation of the original paper document. The copy of the original record should be verified as having all of the same attributes and information as the original record and certified as indicated by a dated signature.

What are ICH-GCP principles?

The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.

Where are source documents recorded?

journal
Any information generated through source documents should be properly recorded in either the company’s journal, accounting software, or financial books. After the initial recording, all documents should be preserved and organized into a file and put into a system so they can be retrieved at any time.