Special requirements concerning Informed Consent form (Part-2)
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- Опубликовано: 4 окт 2024
- In this lecture, I have discussed ICF (Informed consent form) which is a very important document in a clinical trial.
Items You’ll Find in an Informed Consent Form
Although the language may change depending on the research facility and the study being conducted, informed consent forms must contain some basic information:
It’ll express clearly that this is a research study and explain the purpose for it.
It must contain the anticipated duration of the subjects participation.
A detailed account of any procedures or experimental procedures the participant must complete over the course of the trial.
It must explain any potential risks involved with the trial.
Any discomforts the participant may experience must be disclosed, such as injections.
Expected benefits from research and information on alternative options that could also benefit the participant.
It needs to explain clearly if any medical treatments or compensation are provided in the event of injury. If so, what they consist of. If not, where can pertinent information be found.
A statement listing the rights of the research participant.
Subject must be informed that there may be unexpected risks involved with the study.
Reasons that the participant may be removed from the study by the clinical trial investigator, such as failing to comply with procedures.
Any costs the subject might expect to forego as a result of participating in the study.
What will happen if the participant leaves the study before completing it.
A statement that the participant will be informed of any important findings the study yields.
The anticipated number of subjects to be enrolled in the trial.
A statement of confidentiality regarding the data gathered from the study.
Must disclose how any records regarding the participant will stored and filed.
Subject must be made aware that their records may be inspected by the FDA.
Contact information for any questions and concerns about the study must be provided.
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Good 👍🏼 video
This video is really help full👍👍
Thank you so much. Stay connected!
I love to watch ur videos again and again
That's soo nice of you Priyanka. If you have any more doubles and confusions you can ask me on LinkedIn or Instagram. 😊
మీ టు
So informative. Great work❤!!
Thank you Charvi. Its good to know that you liked the lecture.
No words mam...thank u so much
Most welcome 😊
Who cannot participant in clinical trials?