Completing the Amendment Review Application

The first section of the Amendment Review Application is prepopulated by CIRB staff and is not open to edits. Review the information in these fields and click Next. If you notice an error, please contact the CIRB Operations Office using the emails listed above.

• Header section: OMB boilerplate language regarding the purpose of the application and estimated time to complete the application.
• Study ID: Prepopulated.
• Study Title: Prepopulated.
• Protocol Version Date: Enter the protocol version date (PVD) of the protocol and consent form(s) being submitted.
• Event: Prepopulated.
• Study Chair: Prepopulated based on the protocol received from PIO.
• Eligible Population: What is the eligible population for this study. Select the option that applies from the list.
• What type of submission is this? Select the correct type (Amendment, Participant-Directed or Recruitment Material or both if applicable)
• Changes in response to a CTEP Request for a Rapid Amendment (RRA): elect Yes/No.
• Were the changes made in response to a Type 1 Action Letter. Select Yes/No.  If Yes, attach relevant documents.

• Question 2.1: Briefly outline what has been modified in the amendment. Use clear, simple terms so the reviewer can quickly understand the changes.
• Question 2.2: Explain why the changes were made. State the reason for the changes. Keep the explanation concise and relevant to the amendment.
• Question 2.3: Identify if the changes are minor. Select Yes, if the changes do not affect study design, scientific purpose, participant group or participant risk. Otherwise select No.
• Question 2.4: Assess impact on participant risk or benefit. Indicate if the changes alter the risks or benefits for current or future participants. If yes, give a brief explanation for your assessment.
• Question 2.5: Are the changes in the amendment related to significant new findings. Select Yes if the amendment responds to important new findings. If yes, summarize these findings and explain how they led to the amendment.
• Question 2.6: Changes in financial conflict interest. State if the financial conflict of interest status of the study Chair or any listed personnel has changed. If yes, explain the change briefly.
• Question 2.6.1: New or Revised Financial Conflicts of Interest. Indicate if any updates create new or revised financial conflicts of interest for the Study Chair or listed personnel. Select Yes if the change meets the NCI/DCTC policy for Phase 2 or 3 trials, otherwise select No.
  Attach the coordinating group’s plan that explains how any new or updated financial conflicts noted in Question 2.6 will be handled.  
• Question 2.7: Potential Impact on participant willingness. Indicate if the changes could meaningfully affect a participant’s willingness to stay in the study. Select Yes if the change could cause concern or alter a participant’s decision to continue. If yes, briefly explain why and describe the potential impact.
• Question 2.8: Waiver or Alteration of Informed Consent. State if you are requesting a waiver or change to the informed consent process. If Yes, select the type of waiver being requested. Ensure your request is consistent with applicable regulatory criteria.

Complete this section only if you are requesting a waiver of informed consent or an alteration to required consent elements

Instructions:

• Provide all answers in plain language.
• If you cannot provide an answer or it is not applicable, explain why.

• Include the protocol section and page number where the information can be found.

   

• Question 1: Type of Waiver or Alteration: Specify whether you are requesting a full waiver of informed consent or an alteration to specific consent elements.
• Basic Elements of Consent: Refer to the CFR 4546.116(b) for more information. All basic elements of informed consent must be included in the study unless a waiver has been approved. Confirm whether each element is included for your study by selecting the applicable options from the list provided.
• Additional Elements: Refer to the CFR 4546.116(c) for more information. Address the elements below only if they apply to your study. If they are relevant, they must be included unless a waiver has been granted (select all that applies).
• Waiver of Informed Consent- Activities and Rationale. Describe the study activities and explain why a full waiver of consent is needed.
• Question 2: Minimal Risk. Indicate if the study involves only minimal risk to participants by selecting Yes or No. In the text box, describe the study activities and give reason for your answer. Refer to the CFR 46 116 (d)(1)/  46 116 (f)(3)(i) for more information.
• Question 3: Practicality without waiver. Indicate whether the study can move forward only if the waiver or alteration is in place by selecting Yes or No.  In the text box, explain why the waiver or alteration is essential for conducting the study. In the text box below give the reason for your answer. Refer to the CFR 46 116 (d)(3) / 46 116 (f)(3)(ii) for more information.
• Question 4: Identifiable Information or Biospecimens. Indicate if the research requires using information or specimens that remain identifiable. Select Yes/No/N/A. In the text box give the reason for your answer. Refer to the CFR 46 116 (d)(3) / 46 116 (f)(3)(iii) for more information.
• Question 5: Rights and Welfare. Indicate whether participants’ rights and overall welfare will still be upheld under the waiver or alteration select Yes or No. In the text box, outline how these protections will be maintained. Refer to the CFR 46 116 (d)(2) / 46 116 (f)(3)(iv) for more information.
• Question 6: Information After Participation. Indicate if participants or their representatives will be given follow-up information, when relevant. Select Yes/No/N/A. In the text box, explain what information will be shared and the timing of that communication. Refer to the CFR 46 116 (d)(3) / 46 116 (f)(3)(iii) for more information

Complete this section only if you are requesting a Waiver of Documentation of Informed Consent

Instructions:
 

• Provide all answers in plain language.
• If you cannot provide an answer or it is not applicable, explain why.
• Include the protocol section and page number where the information can be found.

• If you find you have any questions about completing this Worksheet, contact the CIRB Operations Office Staff or the CIRB Helpdesk OR 888-657-3711 or refer to the Waiver of Consent (WoC) Quick Guide.

   

• Question 1: Record Linking Subject and Research. Indicate if the only record linking participants to the study is the signed consent form, and if confidentiality will be the main risk if it were present?. Note: If Yes, each participant should be asked whether they want documentation linking them to the study. Refer to 46.117(c)(1)(i) for more information.
  Select Yes/No and explain the reason for your response.
• Question 2: Minimal Risk of Harm. Does the study involve only low-risk activities and avoid procedures that usually  need written consent in regular medical care? Select Yes/No. 
  If Yes, explain why the activities are considered low risk. Refer to the CFR 46 117(c)(1)  for more information.
• Question 3: Indicate if participants or their representatives are from a cultural group where signing forms is not common, the study is considered low risk, and consent will be documented in another suitable way. Select Yes/No/N/A. Refer to the CFR 46 117(c)(1)(iii) for more information. Provide a reason for your response in the text box.
• Question 4: Indicate if participants or their representatives will be given a written statement about the study. Please note that a “Yes” is not required  but the IRB may still decide that the participants or their representatives must receive a written statement.
  Refer to the CFR 46 1167(c)(2) for more information. Provide a reason for your response in the text box.

If changes are made because of Rapid Amendment, new findings, or anything that could affect a participant’s willingness to stay in the study, participants must be informed. At the Study Chair’s discretion participants may also be notified when significant new information arises, even if it does not directly impact their decision to continue.

• Question 3.1: Participant Notification Required. Indicate if participant notification is required by selecting Yes or No.
  If no, Indicate the reason.
• Question 3.2: Participants to be notified. 
  Specify which participants must be informed by selecting the options that apply.
• Question 3.3: How Participants will be Informed of the changes. 
  Note that most participants’ materials must be submitted to the CIRB for approval before they are distributed.
  Exceptions apply only when.
  Changes are needed right away to remove immediate hazards. Refer to 45 CFR 46.103(b)(4) and 21 CFR 56.108(a)(4).
  When the study materials include new study results that could affect participant’s choice to stay in the study.
  Choose the option that applies from the list. 
  If you select “Other”, briefly explain what it refers to in the text box below.
• Question 3.4: State when participants will be told about the changes. Select the option that applies.
  If you select “Other”, briefly explain what it refers to in the text box below.

INSTRUCTION

Provide detailed information for each investigational medical device used in the study. Use the "Repeat" option on the form to create new entries for each device.

• Indicate if the study is using an Investigational Medical Device.
  Select Yes/No.
• Indicate whether any device used in this study meets the FDA’s definition of an investigational medical device. (See the instructions for more details) Select Yes/No.
• Confirm if it is a new device or one not previously reported to the CIRB. Select Yes/No.
• Report any updates/changes to devices previously submitted. Select Yes/No. 
  If Yes, briefly describe the changes in the text box.
• Device Information. For each device being used, complete the following fields:
  Enter the common or proprietary name. 
  Enter the name of the manufacturer.
• Indicate the current FDA status of the device. Refer to FDA Registration and Listing, Approvals and Clearances, or 510(k) Exemptions databases for verification.
  Briefly describe any interactions held with FDA regarding the use and regulatory status of the device.
• Supporting Documents. Upload device manuals, safety documents, and other relevant materials.
• Effectiveness/Safety. Indicate whether the study will evaluate the device’s effectiveness, safety, both, or neither.
• Device Classification
  Using FDA guidance indicate if the device qualifies under any listed category (General Wellness Device – Low Risk (select Yes/No), Non-Medical Exercise Equipment (select Yes/No), FDA Exempt Device) (select Yes/No). 
  If you selected Yes for any of the above, briefly explain how it meets the criteria in the text box.
• Risk Determination. If the device does not meet criteria for General Wellness, Non-Medical Exercise Equipment, or FDA exemption, submit it for CIRB risk determination.
  Indicate whether the device is Non-Significant Risk (NSR) or Significant Risk (SR). Summarize any known safety concerns or risks related to the device and rationale for classification. Refer to the FDA’s guidance on Significant Risk and Nonsignificant Risk Medical Device Studies to make a determination.
• Device Accountability.
• Describe how and where the device will be obtained.
• Secure Storage. Describe how the device will be stored securely.
• Dispensing. Describe how the device will be distributed to study participants.
• Use Tracking. Describe how you will monitor use and maintain inventory records.
• End-of-Study Disposal. Describe how the device will be disposed of after the study ends.
• Attach written SOPs if available for device handling and tracking.
• Monitoring Protocol Compliance (Refer to the monitoring plan). Describe how you will ensure the protocol is followed.
• Subject Safety and Data Monitoring. Describe your plan for ongoing data and participant safety monitoring. 
  Attach relevant SOPs if available.

• Question 5.1: Describe the material you are submitting. Briefly explain what the material is. Examples may include flyers, brochures, or educational handout intended for participants.
• Question 5.1.1. If this is an updated version of previously approved material, explain what has changed and why the change was made.  
• Question 5.2: Describe your plan for giving the material to study participants.
  Explain how and when the material will be shared with participants or those thinking about joining the study, include details such as format (paper or digital), delivery method and timeline.

Make sure all the documents that apply are attached in this section.

• Use the checklist to select what you have included.
• Click Add Attachment to upload the files