Question

Managing and Monitoring Clinical Trials

1. Explain the (8) steps you would take to inform consent a subject to a clinical trial.

2. List the requirements to appropriately consent the patient (such as readability level).

Answer 1

Answer 1= The 8 steps are as below=

1. First of all, we have to select the volunteers who can participate in the trail
2. Providing the details and subject information related to the research that has to be carried out
3. It must ensure that the subject has enough time to go through the information provided and has time to consider all the alternatives and options
4. If the subject has any questions, those are needed to be answered completely
5. It must be ensured that all the information and doubts are clearly understood by the subjects
6. Once this is done, we have to get the voluntary informed consent from the volunteer to participate in the trial
7. All the related information must be informed to the volunteer during the entire trial
8. We have to re-affirm the consent of the volunteer again during the entire process of trial

Answer 2- The main requirements to appropriately consent the patient are as below-

First of all, it must be ensured that the consent id given voluntarily without any sort of pressure, misrepresentation of information coercion.

second, the person who has to give the consent must be competent to understand the facts and provide the consent and in case he or she is not competent then the person or representative must have the legal authority to do so