What is source documents in research?

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 is Alcoa in GCP?

ALCOA – Elements of Good Documentation. Issued: March 2021. Training and Resources. Thorough documentation is pivotal to Good Clinical Practices (GCP). GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or research studies.

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 is the importance of 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.

What are source documents and how important is it to keep them?

What are Source Documents? Source documents are the physical basis upon which business transactions are recorded. Source documents are typically retained for use as evidence when auditors later review a company’s financial statements, and need to verify that transactions have, in fact, occurred.

What is ICH and GCP in clinical research?

Abstract. The Good Clinical Practice Guideline of the International Conference on Harmonization (ICH-GCP) is an international ethical, scientific and quality standard to harmonize technical procedures and standards, improve quality, speed time to market the drug.

What is GDP in clinical research?

The GDPs are an internationally accepted practice by which research and manufacturing data is documented and preserved.

What are source documents GCP?

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.