Management of Research Study Protocol Submission
This file provides detailed Standard Operating Procedures for the submission of research study protocols and related documents. It outlines the responsibilities of the Institutional Ethics Committee (IHEC) and the process for managing submissions. Ideal for researchers and administrative staff involved in research documentation.
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How do I fill this out?
To fill out this form, start by gathering all required documents for submission. Ensure that each document meets the specified guidelines for review. Finally, submit the completed application along with the necessary copies and forms to the IHEC office.
How to fill out the Management of Research Study Protocol Submission?
1
Gather all required documents including the research proposal.
2
Complete the IHEC project submission application form.
3
Check that all items on the checklist are included.
4
Submit the application at least 30 days before the meeting.
5
Confirm submission of any SAE reports as per the guidelines.
Who needs the Management of Research Study Protocol Submission?
1
Researchers who need ethics approval for their studies.
2
Institutional staff managing the ethics submission process.
3
Ethics Committee members reviewing submitted protocols.
4
Legal advisors ensuring compliance with regulations.
5
Students conducting research requiring institutional oversight.
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What are the instructions for submitting this form?
To submit this form, email it directly to the IHEC office at ihec@kims.edu. You can also fax your documents to (123) 456-7890. For physical submissions, please mail to IHEC Office, KIMS Campus, City, State, ZIP. Ensure you adhere to all deadlines specified in the SOP for timely processing.
What are the important dates for this form in 2024 and 2025?
In 2024, be aware of submission deadlines which will be communicated by the IHEC. Keep track of meeting dates to ensure timely submission, especially for protocols requiring initial review. Similar timelines will apply in 2025, so planning ahead is crucial.
What is the purpose of this form?
The purpose of this form is to standardize the process of submitting research study protocols and related documents for ethical review. By following this SOP, researchers ensure that their proposals are reviewed in a timely manner and that ethical guidelines are adhered to. The form also facilitates clear communication between the research team and the Institutional Ethics Committee.
Tell me about this form and its components and fields line-by-line.
- 1. Research Proposal: A comprehensive document outlining the research project.
- 2. Submission Application Form: Form used to submit proposals for initial review.
- 3. Checklist: A list of required documents to confirm completeness.
- 4. Duty Delegation Log: Log detailing delegation of responsibilities within the study team.
- 5. Conflict of Interest Document: Form signed by the PI declaring any potential conflicts.
What happens if I fail to submit this form?
Failure to submit this form may result in delays to the research project. Additionally, the research team may not receive necessary ethical approval to proceed, which could halt the study altogether.
- Delayed Research: Failure to obtain timely approval may delay the start of your research.
- Compliance Issues: Not following submission protocols can lead to compliance issues with ethics regulations.
- Inability to Proceed: Without approval, research projects may face stoppage or challenges in conducting studies.
How do I know when to use this form?
- 1. Initial Protocol Submission: Use this form when submitting a new research proposal for initial ethics review.
- 2. Protocol Amendments: Utilize this form for submitting any amendments to previously approved protocols.
- 3. SAE Reporting: This form is also applicable for reporting serious adverse events related to approved studies.
Frequently Asked Questions
How do I submit my research proposal?
You can submit your proposal through the IHEC office, ensuring all required documents are included.
What documents are needed for submission?
Required documents include the research proposal, submission application form, and any relevant attachments.
Can I make changes to my submission after it is submitted?
Yes, changes can be made if necessary, but it's best to consult with the IHEC for guidance.
How long does the review process take?
The review process typically takes several weeks, depending on the number of submissions and the complexity of each protocol.
Who reviews the submitted protocols?
Protocols are reviewed by members of the Institutional Ethics Committee who are qualified in the relevant areas.
Do I need to submit hard copies of my documents?
Yes, hard copies are required along with any electronic versions that may be needed.
What happens if my submission is incomplete?
If your submission is incomplete, the IHEC Secretariat will reach out for clarification and missing documents.
How can I ensure my application is complete?
Use the checklist provided in the SOP to confirm that all necessary documents are included in your submission.
Is there a specific format for the research proposal?
Yes, the research proposal should follow the guidelines set out by the IHEC for clarity and structure.
What do I do if I encounter issues with the PDF?
If you encounter issues, you can use the online help tools or contact support for assistance.
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