Get Checklist For Patient Information Sheet And Informed Consent Form - Nih Gov

Filling out the Checklist for Patient Information Sheet and Informed Consent Form is an essential step in ensuring ethical research practices and safeguarding the rights of participants. This guide provides you with step-by-step instructions to complete the form effectively online.

Follow the steps to fill out the form correctly

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Review the general information section, which includes fields for study title, protocol identifying number, sponsor's name and address, local investigator details, and declarations of conflict of interest. Ensure all details are accurately filled in.
3. Complete the background and literature review section by providing comprehensive information about the disease or condition being studied, along with known risks and potential benefits of the investigational product.
4. Clearly state the objectives and purpose of the study, emphasizing its societal value and the specific objectives.
5. Address ethical issues within the study, articulating how these will be managed throughout the trial.
6. Outline the trial design by mentioning study endpoints, procedures, and measures taken to reduce bias, such as randomization.
7. Describe the treatment and procedures, including permitted medications, dosage, and any protocols for adverse events.
8. Detail the assessment methods for efficacy and safety, outlining the process and timing for monitoring participants.
9. Ensure confidentiality by discussing how personal information will be protected, including access rights for subjects.
10. Review the financial aspects, including any insurance or indemnity letters from the sponsor, and discuss the publication policy regarding confidentiality.
11. Conclude by reviewing the involvement of vulnerable subjects, ensuring that appropriate assent forms and protections are in place.
12. Once all fields are filled, save your changes, and proceed to download or print the form as necessary.

Complete and submit your documents online to ensure compliance and protect participants.