Category: Research Paper

Which FDA regulation covers informed consent? regulations on Protection of Human Subjects What is the common rule in clinical research? The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding. […]

What is CFR standard? The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Why is software validation needed? Software Validation […]

How do you know a story is successful? Tell Stories that Sell: the Best Customer Success Story Template Address the challenges your target audience face. Embrace the authenticity of a real client. Ease any concerns potential customers may have. How do I write my own success story? How to Write a Success Story Step 1: […]

Can you write in first person in a research paper? Yes! For example, the first person is more likely used in the abstract, introduction, discussion, and conclusion sections of an academic paper while the third person and passive constructions are found in the methods and results sections. … Can I write in first person using […]

Is a pacemaker a significant risk device? A pacemaker that is a modification of a commercially available pacemaker poses SR because the use of any pacemaker presents a potential for serious harm to the subjects. This is true even though the modified pacemaker may pose less risk, or only slightly greater risk, in comparison to […]

How do you say I in academic writing? Never use “I,” “my,” or otherwise refer to yourself in formal academic writing. You should also avoid using the second-person point of view, such as by referring to the reader as “you.” Instead, write directly about your subject matter in the third person. How do you refer […]

How do you invite someone to be a co-author? Just sent him/her an email with a brief summary of the ideas you are interested in and ask him/her if he/she is interested on the project, it has worked for me. Otherwise, try to attend one of his/her talks and approach him/her and the end of […]

Which of the regulations are applicable in research and development phase? R&D activities in regulated laboratories are performed in compliance with GLP, GMP and good clinical practice (GCP) as appropriate. GLP is not required for basic research, studies to develop new analytical methods, initial pharmacology or proof-of-concept studies; therefore, Part 11 compliance is also not […]

How do you Analyse qualitative data in Excel? You can use Excel to code and track themes in your qualitative data. You can create new themes and sub-themes in additional columns and clearly see what themes each participant’s responses relate to. Create a new Excel worksheet tab for each question so your data stays organized […]

What is a significant risk device? Significant Risk Device Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health. Which risk device studies must have an IDE application approved by FDA before […]