Write a research paper about conducting clinical trials internationally.

I want to write a research paper about conducting clinical trials internationally.

First it should briefly mention the elaboration of the idea and concept. which is the preplanning phase. (brief)

2. Planning phase: what to do about budgeting like Planning grants (e.g. NIH clinical trial planning grant program). What regulations to take into considerations like FDA and the country in which the research will be done. What are the regulatory agencies in Latin america and europe? Also, legal aspect, who is responsible for adverse events etc? What ethical issues do we need to watch for? International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS)–>what is essentially what we need to comply with according to this guidelines.

b. Protocol development: Methods, training of personnel. (brief)

3. Execution phase: should you hire a CRO or do it yourself?

a. Obtaining IRB approval

i. Techniques that facilitate the IRB approval of protocols,Variability among IRBs decisions and how to prevent them.

4- Data capture. How do we maintain data security and how do we store it. what are the requirements that countries in latin america and europe have for data encryption. what strategies can we use to deidentifying electronic records.

5- How to determine authorship