What are the requirements for a civil document?
Please refer to the Document Finder to learn about the civil document requirements for each country. Please note that all documents not written in English, or in the official language of the country from which you are applying, must be accompanied by certified translations.
What is not documented is not done in clinical research?
Any basic training in clinical research will definitely include these phrases: ‘What is not documented is not done!’ ‘Document what is done as well as what is not done!’ Roots of good documentation principles are in the ICH-GCP where source data and source document is first defined.
What does documentation mean in a research paper?
In a report or research paper, documentation is the evidence provided for information and ideas borrowed from others. That evidence includes both primary sources and secondary sources. There are numerous documentation styles and formats, including MLA style…
Where do I get my civil documents from?
Your civil documents MUST be issued by the official issuing authority in your country. Please refer to the Document Finder to learn about the civil document requirements for each country.
Please refer to the Document Finder to learn about the civil document requirements for each country. Please note that all documents not written in English, or in the official language of the country from which you are applying, must be accompanied by certified translations.
Your civil documents MUST be issued by the official issuing authority in your country. Please refer to the Document Finder to learn about the civil document requirements for each country.
When does a research participant need to be approved by the IRB?
Documentation that an alteration or waiver of research participants’ authorization for use/disclosure of information about them for research purposes has been approved by an IRB or a Privacy Board. See 45 CFR 164.512 (i) (1) (i).
What are the requirements for disclosure of protected health information?
To use or disclose protected health information with authorization by the research participant, the covered entity must obtain an authorization that satisfies the requirements of 45 CFR 164.508. The Privacy Rule has a general set of authorization requirements that apply to all uses and disclosures, including those for research purposes.
