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NCCIH Clinical Research Toolbox | NCCIH
- https://www.nccih.nih.gov/grants/toolbox
- The NCCIH Clinical Research Toolbox provides a web-based information repository for investigators and staff involved in NCCIH-funded clinical research. The Toolbox …
Clinical Trials Guidance Documents | FDA
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
- Jan 31, 2023
Clinical Research Study Investigator’s Toolbox
- https://www.nia.nih.gov/research/clinical-research-study-investigators-toolbox
ICH Guidance Documents | FDA
- https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents
- Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. …
8. Essential documents for the conduct of a clinical trial …
- https://ichgcp.net/8-essential-documents-for-the-conduct-of-a-clinical-trial
- Filing essential documents at the investigator/institution and sponsor sites in a timely manner ...
Clinical Research Study Investigator's Toolbox
- https://www.hhs.gov/guidance/document/clinical-research-study-investigators-toolbox
- The purpose of the NIA Clinical Research Toolbox is to provide a Web-based informational repository for investigators and staff involved in clinical research. The Toolbox contains …
Good documentation practice in clinical research - PMC
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121265/
- Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy …
Source Documents in Clinical Trials - Clinical Research Info
- https://clinicalresearchinfo.com/source-documents-in-clinical-trials/
- Research documents retention (archiving) at a Medical Institution or hospitals. Documents which are considered as Source Documentation: Informed Consent Forms; …
Documentation in Clinical Research - National …
- https://ccrod.cancer.gov/confluence/download/attachments/71041052/Documentation.pdf
- There are some documents that serve as source documents that are not allowed to be placed in a medical record. However, they need to be maintained as source documents. …
6 different types of medical documents - Okomeds
- https://www.okomeds.com/6-different-types-of-medical-documents/
- Clinical documentation is the patient’s information that includes their biological history and all the information that the healthcare professional attending the patient …
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