What are the source documents in clinical trials?

Published by Anaya Cole on

What are the 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.

What are considered 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 source documents in GCP?

What is source data? The executive order on GCP defines source data as any information in original records and certified copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.

Can CRF act as a source document?

Case report forms (CRFs) may be used as source documents, but in this instance, the protocol should prospectively define which data may be treated in this way.

What does Alcoa mean in clinical research?

The Food and Drug Administration (FDA) first introduced the “ALCOA” concept, Attributable, Legible, Contemporaneous, Original, and Accurate, as the fundamental principles of data quality that research documentation must meet.

What is a source document in data processing?

A source document is the original document that contains the details of a business transaction. A source document captures the key information about a transaction, such as the names of the parties involved, amounts paid (if any), the date, and the substance of the transaction.

How many types of source documents are there?

The most common documents are:

  • Checks.
  • Invoices.
  • Receipts.
  • Credit memos.
  • Employee time cards.
  • Deposit slips.
  • Purchase orders.

What does Alcoa C stand for?

What is Alcoa describe with examples?

ALCOA relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate. These simple principles should be part of your data life cycle, GDP and data integrity initiatives.

What is Alcoa in good documentation practices?

What are source documents in accounting PDF?

Source Document in Accounting In accounting, a source document is created when a business spends or receives money. An example of a source document is a receipt, bill, statement, invoice, check, purchase order, and any other transaction document.

What is Alcoa data?

According to the FDA, data should meet certain fundamental elements of quality. 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 Alcoa standards?

What is Alcoa-C?

All elements of the acronym ALCOA apply to both paper and electronic source data, and the records that hold that data. The degree to which the data fulfills the data quality criteria establishes the acceptability of the data. The table below describes all elements of ALCOA-C.

What is Alcoa and how do you apply it?

All of the elements of the acronym ALCOA must be applied to both paper and electronic source data, and the records that hold that data. Serving as evidence of the events that took place during a study, source documents need to paint the full picture of what happened.

What is source data in Alcoa-C?

When you think about ALCOA-C, you first need a clear definition of source data. According to the FDA, source documentation is any medical record or form kept for a participant before, during, or after the clinical trial procedure.

Why use Alcoa documentation principles as a checklist?

Using ALCOA documentation principles as a checklist for your document management system ensures you’ve embedded full data integrity. Learn more. Menu Find a solution By business need Quality Safety Environmental Regulatory Documents Audit Risk

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