Get the free PROTOCOL AMENDMENT FORM - St Luke039s Medical Center

INSTITUTIONAL ETHICS REVIEW COMMITTEE PROTOCOL AMENDMENT FORM EC Reference #: CT Protocol No. Principal Investigator: Inst.×Dept.: Protocol Title: Note: Kindly check below the document’s) for review:

How to fill out protocol amendment form

How to fill out a protocol amendment form:

1. Start by obtaining a copy of the protocol amendment form from the appropriate authority or organization overseeing the study or project.
2. Read the instructions provided with the form carefully to understand the requirements and guidelines for filling it out correctly.
3. Begin by providing your personal information, such as your name, contact details, and any identification numbers or credentials required.
4. Clearly indicate the title or reference number of the original protocol that requires an amendment.
5. Describe the specific changes or modifications you wish to make to the original protocol in a clear and concise manner. Include relevant details such as the rationale for the amendment and any supporting evidence or literature.
6. If applicable, provide a detailed explanation of the potential impact of the proposed amendment on the study subjects, data collection, analysis, or any other relevant aspect.
7. Consider including any necessary supporting documents or attachments that further support your amendment request. These may include additional informed consent forms, updated risk assessments, revised study protocols, or any other relevant documents.
8. Review your completed form carefully to ensure all required fields have been filled out accurately and completely.
9. Sign and date the form, acknowledging that the information provided is true and accurate to the best of your knowledge.
10. Submit the filled out protocol amendment form to the designated authority or organization, following any specific submission guidelines or procedures they may have in place.

Who needs a protocol amendment form?

1. Researchers or principal investigators conducting a study or project that was originally approved by an ethics committee, institutional review board (IRB), or similar governing body may need a protocol amendment form.
2. Any individual or organization seeking to modify or update specific aspects of a previously approved research protocol may be required to submit a protocol amendment form.
3. It is essential for those who wish to make changes to a research protocol or study design to ensure compliance with ethical guidelines, regulations, and the requirements of the governing authority overseeing the research. Consequently, anyone in need of modifying an approved protocol should consider using a protocol amendment form.

For pdfFiller’s FAQs

What is protocol amendment form?

Protocol amendment form is a document that is used to make changes or updates to an existing protocol for a research study.

Who is required to file protocol amendment form?

Researchers or principal investigators who are overseeing a research study are required to file the protocol amendment form.

How to fill out protocol amendment form?

The protocol amendment form typically requires the individual to provide information about the proposed changes, rationale for the changes, and any potential impact on study participants.

What is the purpose of protocol amendment form?

The purpose of the protocol amendment form is to ensure that any changes to a research study are properly documented and reviewed to maintain the integrity of the study.

What information must be reported on protocol amendment form?

The protocol amendment form must include details about the proposed changes, the reason for the changes, any potential risks or benefits, and any modifications to study procedures.

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