Available submission actions are displayed in the Submission Actions menu on the left-hand side of the submission workspace. Actions are divided into activities and forms.

Your Activities

Change Submission Type

The Change Submission Type activity allows you to change the following submission types:

• A Continuing Review submission to a Termination submission, or vice versa.
• An SAE/UADE, Unanticipated Problem, or Safety Report reportable event submission to another submission of those types.

This can be useful if you created one type in error and you later want to change it to another type. This activity is only available when a submission is in the Pre-Submission or Administrative Clarifications Required status.

To change a submission's type, complete the following steps:

1. Click the Change Submission Type activity.
2. In the window that opens, select the new submission type in the Submission Type drop-down list. If only one submission type is available, that type is selected by default and can't be changed.
3. You can optionally enter a comment in the Comments field.
4. Click OK.
5. In the confirmation window that opens, click OK.

When you submit this activity, the submission type is changed to the selected type and the submission status reverts back to Pre-Submission. When the page refreshes, the submission's new or updated forms are displayed. You can complete the forms and submit the submission to the IRB when you're ready to proceed.

Note that when you change an SAE/UADE, Unanticipated Problem, or Safety Report reportable event submission to another type, the following changes are made to the Safety Report Lead-In submission form:

• SAE/UADE Report to Safety Report: The responses to all but the last question are preserved, and the response to the last question is changed to No.
• SAE/UADE Report to Unanticipated Problem Report: The responses to all previous questions are preserved, and a new question is displayed and requires a response.
• Unanticipated Problem Report to Safety Report: The responses to the fourth and fifth questions are changed to No, the previous sixth question ("What date did you do...") is no longer displayed, and a new sixth question ("Because you selected 'No'...") is displayed and given a response of No.
• Unanticipated Problem Report to SAE/UADE Report: The responses to the fourth and fifth questions are changed to No, the previous sixth question ("What date did you do...") is no longer displayed, and a new sixth question ("Because you selected 'No'...") is displayed and given a response of Yes.
• Safety Report to SAE/UADE Report: The responses to the fourth and fifth questions are preserved, the response to the sixth question ("Because you selected 'No'...") is changed to Yes, and the response to the seventh question ("You have indicated...") is preserved and view-only.
• Safety Report to Unanticipated Problem Report: The response to the fourth and fifth questions are changed to Yes, the previous sixth question ("Because you selected 'No'...") is no longer displayed, and a new sixth question ("What date did you...") is displayed and requires a response.

When a submission type is changed, the Submission History log and attachments from the pre-conversion submission are preserved on the converted submission. Clarifications from the pre-conversion submission aren't preserved.

Contact IRB

The Contact IRB activity allows you to send a message to the submission’s assigned Client Services Coordinator at Advarra.

Note that for most submission types, this activity isn't available when the submission is in the Pre-Submission or Awaiting Assignment status because an appropriate recipient hasn't yet been assigned to the submission. As an exception, this activity is available for continuing review and termination submissions in all statuses including Pre-Submission and Awaiting Assignment.

To contact the IRB, complete the following steps:

1. Click the Contact IRB activity.
2. In the window that opens, enter a message in the free-text field.
3. You can optionally attach a file to the message by clicking Add Document. In the window that appears, drag and drop the attachment or click Browse to browse your computer for the attachment file and then click Submit Document.
4. Select whether you'd like to receive a copy of your message via email. Note that if you opt in, a copy of the message will be sent to all submission contacts. This field is required.
5. Click OK. Your message is sent.

Edit Contact and Notifications/Edit Site Contacts

These activities allow you to edit the contacts/personnel for a protocol or site submission, manage other users’ access to the submission, and select which submission-related notifications users with access should receive. Note that you can only add users whose accounts are in Pending, Registered, Locked, or Active status to submissions; you cannot add Inactive users to submissions.

In the event of any personnel changes within your organization, it’s your responsibility to update submission contacts or to request that CIRBI Product Support updates submission contacts on your behalf.

Edit Primary Point of Contact

This section of the activity allows you to appoint someone as a primary point of contact for the submission. A point of contact is required to be assigned to a submission at all times. Note that only one user can be assigned as the submission's point of contact at one time.

To edit a protocol submission’s primary point of contact, complete the following steps:

1. Click the Edit Contact and Notifications activity.
2. In the window that opens, navigate to the Primary Point of Contact section and click the Select User button.
3. In the right slider that appears, you can select a filter (Name, Email, or Organization) from the Filter By drop-down list and enter a keyword to search for a user, or you can click the Advanced button to filter by all three.
   • If the person you are searching for isn’t listed, they either don’t have a CIRBI account or are associated with a different organization than yours in CIRBI.
     • If they don’t have an account, they must first create one before you can add them as a contact.
     • If they are associated with a different organization in CIRBI, enter their full email address in the provided field.
4. Select the radio button for the user you want to assign as the submission’s point of contact and then click the Close button.
5. Click the OK button in the main window to save your changes.

To remove the current primary point of contact in order to replace them with another user, click the X icon to the right of the current contact's listed information.

Edit Team Members/Administrative Personnel

This section of the activity allows you to give users access to the submission. To edit the submission’s team members (for protocols) or administrative personnel (for sites), complete the following steps:

1. Click the Edit Contact and Notifications or Edit Site Contacts activity.
2. In the window that opens, navigate to the Team Members section (for protocols) or Administrative Personnel section (for sites) and click the Add Team Member button.
3. In the right slider that opens, click the Add Team Member button.
4. In the second right slider that appears, you can select a filter (Name, Email, or Organization) from the Filter By drop-down list and enter a keyword to search for a user, or you can click the Advanced button to filter by all three.
   • If the person you are searching for isn’t listed, they either don’t have a CIRBI account, their CIRBI account is inactive, or they're associated with a different organization than yours in CIRBI.
     • If they don’t have an account, they must first create one before you can add them as a contact.
     • If they are associated with a different organization in CIRBI, enter their full email address in the provided field.
5. Select the radio button for the user and then click the Close button.
6. In the first right slider, make the following selections for user you selected:
   • Assign a submission role to them.
   • Indicate whether or not they should have editing privileges for the submission. Granting them editing privileges also allows them to create modifications, continuing review/termination reports, and prompt reporting events for the submission, as applicable.
   • Indicate if they should be copied on emails from the IRB regarding the submission.
   • Indicate their contact preferences, such as which protocol-related or site-related (if applicable) notifications they should receive. Note that this selection isn't applicable to generic materials submissions.
7. Click the Add This User button to finish, or click the OK & Add Another button to add the user and then add another user.
8. Click the OK button in the main activity window to save your changes.

To remove a contact from the list, click the X icon to the right of their listed information. To edit a contact’s role or notification preferences, click the pencil icon. You must click OK once this step has been completed in order to save your changes.

Note that the Phone Number field reflects the Phone Number value as it appears in the contact's account profile. If the Phone Number value in the contact's profile is blank, the Office Phone Number value in their profile is displayed instead.

Provide Sponsor/CRO Sign-off

The Provide Sponsor/CRO Sign-off activity is available for site-level submissions (including site modifications, continuing reviews, termination reports, and reportable events) when sponsor/CRO approval of the submission has been requested. If sign-off is requested, you will receive an email from CIRBI indicating the site has submitted and that your sign-off is required. Only users with the Client Protocol CRO or Client Protocol Sponsor role who have permission to edit the corresponding protocol submission can access and submit this activity.

To review the site’s submission, click the link to the site submission in the notification email you received, or click the plus icon (+) on the Site Information section of the protocol’s submission workspace and then click the site submission's ID link. On the page that opens, click the Submission Forms button to review the forms that the site submitted in their initial application, such as the Informed Consent Document form which outlines the site’s proposed ICF details.

To provide sponsor/CRO sign-off, complete the following steps:

1. Click the Provide Sponsor or CRO Sign-off activity.
2. In the window that opens, you can select whether the IRB can proceed with IRB review:
   • If the site submission's information is correct, select Yes to the first question. You can optionally enter additional comments or attach documents to your sign-off.
   • If it’s incorrect, select No the first question and then provide additional comments and/or documents about the inaccuracies. If you select No, the assigned submission coordinator will contact the site after you submit this activity to follow up with them about the information in their application.
3. To submit the form, click Confirm.

Note that you should only provide this sign-off if you’re authorized to do so by your organization.

Provide Institutional Sign-off

The Provide Institutional Sign-off activity is available when institutional approval of a submission’s IRB review has been requested by the IRB. When this has been requested, the submission transitions to the Waiting Institutional Sign-off status. Whether or not institutional sign-off is required is typically indicated during the initial study submission process; it might not be required for all studies or sites. Only users with the Client Institutional Administrator role can access and submit this activity.

If institutional sign-off for a submission has been requested by Advarra, you receive an email from CIRBI indicating that sign-off is required in order for IRB review to proceed. You can click the link in the email to navigate directly to the submission workspace.

To provide institutional sign-off, complete the following steps:

1. Click the Provide Institutional Sign-off activity.
2. In the window that opens, indicate whether the IRB can proceed with IRB review. You can optionally enter additional comments or attach documents to the sign-off.
3. To submit the form, click Confirm.

Note that you should only provide this sign-off if you’re authorized to do so by your organization. 

Send To Trash

If you need to discard a submission you started but haven't submitted, you can use the Send To Trash activity. This activity is only available when the submission is in the Pre-Submission status.

To send a submission to trash, complete the following steps:

1. Click the Send To Trash activity.
2. In the window that opens, enter a reason for discarding the submission in the Comments field. This field is required.
3. Click OK. The submission is discarded.

Submit Clarifications

Refer to the Clarifications page.

Submit ICF Comments

The Submit ICF Comments activity is available when informed consent forms have been provided for your review. When you’ve reviewed the ICFs and are ready to provide feedback, you can use the Submit ICF Comments activity to provide feedback or a marked-up copy of the ICF for Advarra IRB to review.

To submit ICF comments, complete the following steps:

1. Click the Submit ICF Comments activity.
2. In the window that opens, enter your ICF feedback or message to IRB staff in the Message to IRB staff field. This field is required.
3. You can optionally attach a marked-up copy of the ICF or other documents to the activity by clicking Add Document. In the window that appears, drag and drop the attachment or click Browse to browse your computer for the attachment file and then click Submit Document.
4. Click OK. Your ICF comments are sent to the IRB and the submission status changes to Post Review.

Submission Forms

When a protocol or site submission has been approved and IRB-issued documents have been provided, additional forms are made available in the left menu for protocol events that you might need to report or submit to the IRB throughout the duration of the study, such as modifications or reportable events.

Continuing Review Submission

The Continuing Review Submission form allows you to submit a continuing review report for the submission. Continuing review submissions are required to be submitted prior the expiration date listed on the submission workspace. CIRBI automatically sends you reminders to submit a continuing review submission in a sequence of 60, 29, 22, and 10 days prior to the submission’s expiration date. Note that continuing reviews submitted within 2 weeks of the expiration date might be subject to additional costs. Additionally, late continuing review submissions might cause a lapse in the submission’s IRB approval.

Note that this form isn't available when a termination submission is currently in progress for the same submission.

Protocol Type Considerations

Single-site protocols or site submissions: When you submit the Continuing Review Submission form for a single-site protocol submission or a site submission, the continuing review is only applicable to that protocol or site submission. For site submissions, you must answer the questions only as they pertain to your site.

Multi-site protocols: For multi-site protocols, the Continuing Review Submission form must be submitted separately for the protocol submission and each affiliated site submission. Site submissions can submit a continuing review submission before the protocol submission submits one; in this scenario, the site submission’s status is updated to Waiting for Protocol CR until the protocol-level continuing review is received by Advarra. When you submit the form for a multi-site protocol submission, the continuing review is applicable to the protocol but not to the affiliated sites. If the protocol submission and multiple or all sites have submitted continuing reviews by the time Advarra begins processing, Advarra will process them simultaneously. If any site submissions haven’t yet submitted a continuing review by the time Advarra begins processing the protocol and the sites which have submitted, Advarra independently processes the “straggling” sites later.

To submit a continuing review submission, complete the following steps:

1. Click the Continuing Review Submission form.
2. In the window that opens, complete the forms that are displayed by answering questions about the study’s or site’s current enrollment status and rates, safety profile, subject risks, data monitoring, study changes, pending reports, standard of care, regulatory status, published literature, and other potential changes as applicable. Use the Save, Save & Previous, and Save & Next buttons to navigate between forms and save your work.
   • If you indicate that unreported unanticipated problems involving risks to human subjects have occurred during the study, you will additionally be prompted to submit a Safety Report form in CIRBI.
3. For single-site protocol or site submissions: Complete additional forms that are displayed by answering questions about site enrollment, subject numbers, unanticipated problems, changes, protocol deviations, other IRBs, inspection reports, the site initiation visit date, and other potential changes as applicable.
4. Click the Submit button.
5. In the window that opens, click the Submit Application button.

You will navigate to the continuing review’s submission workspace and the continuing review submission will enter the Administrative Review status. When the continuing review submission is received by Advarra, you’re sent an acknowledgement email. You’ll be informed of next steps through notifications and updates to the submission.

When a continuing review is processed and approved by Advarra, the continuing review submission’s status is updated to the CR Complete status and the expiration date is updated in the protocol and/or site submission workspace.

Termination Submission

The Termination Submission form allows you to submit a request to terminate (close out) a protocol or site submission. Termination submissions are only processed administratively by Advarra and aren’t reviewed by the IRB. You can only submit termination submissions for protocol or site submissions in the following submission statuses:

• Approved
• Suspended
• Approved With No Continuing Review Required
• Exempt Confirmed
• Non Human Research Determination

Note that this form isn't available when a continuing review submission is currently in progress for the same submission.

Protocol Type Considerations

Single-site protocols or site submissions: When you submit the Termination Submission form for a single-site protocol submission or a site submission, the termination is only applicable to that protocol or site submission.

Multi-site protocols: For multi-site protocols, the Termination Submission form must be submitted separately for both the protocol submission and each affiliated site submission. Advarra can’t process the termination of a protocol submission until each affiliated site submission has submitted their own termination report.

To submit a termination submission, complete the following steps:

1. Click the Termination Submission form.
2. On the page that opens, complete the forms that are displayed by answering questions about the study’s current enrollment status, number of active subjects and follow-ups, pending reports, and enrollment date details. Use the Save, Save & Previous, and Save & Next buttons to navigate between forms and save your work.
   • If you indicate there are pending safety reports (such as unreported deviations or subject complaints), you will not be able to proceed with the termination submission and you will be required to first submit those reports via CIRBI.
3. Click the Submit button.
4. In the window that appears, click the Submit Application button.

After it’s submitted, the termination submission will enter the Administrative Review status and you’re sent an acknowledgement email. You’ll be informed of next steps through notifications and updates to the submission.

When a termination is processed and approved by Advarra, the submission status is updated to the Terminated status and the termination date is populated in the submission workspace.

Modification

The Modification form allows you to submit a modification to an approved submission. Some reasons you might need to submit a modification include:

• Revisions to IRB-approved informed consent forms, such as to augment consent form language or revise the listed contacts
• Change of principal investigator or research location
• Protocol amendments
• Request site-specific translations
• Revisions to subject-facing materials

To submit a modification, complete the following steps:

1. Click the Modification form.

2. On the page that opens, complete the initial form by answering questions about the reason for the modification, if informed consent form changes are required, and the current enrollment status of the protocol. Note that available modification types vary depending on whether you are submitting the modification at the protocol level or at the site level. Modification types are defined below:

   • Protocol Documents: Changes are being made to the research that result in a revised protocol, an administrative letter, or a protocol amendment that impacts the IRB-approved protocol.
   • Consent Documents: Updates are being made to previously-approved consent forms, or new consent forms are being introduced to the study.
   • Product Information: Revisions are being made to product information, such as the investigator’s drug brochure or device package insert.
   • Translation of Documents: Requests to have the IRB either translate or review translations of informed consent documents, recruitment/subject materials, or other study documents.
   • Change of Principal Investigator: The principal investigator associated with the submission needs to be changed.
   • Recruitment/Subject-Facing Materials: Revisions need to be to previously-approved recruitment/subject-facing materials or requests for new recruitment/subject-facing materials.
   • Investigational/Research Location Information: Adding, removing, or updating site locations.
   • Appeal to IRB Restrictions: Requests to appeal IRB decisions related to prior submissions, such as protocol approvals or modifications.
   • Disclosure of Conflict of Interest: New or updated information regarding a conflict of interest for study personnel or the PI.
   • Request for HIPAA Waiver: Submitting a request to use and disclose Protected Health Information (PHI) for a research study without obtaining individual patient authorization.
   • Change to Sub-Investigator(s)/Co-Investigator(s): When a sub-investigator or co-investigator needs to be changed.
   • eConsent: Requests to use eConsent for the study.

   When you've made a selection, click Save & Next to navigate to the next form.

3. For multi-site protocol submissions: On the following form, select the sites affected by this modification. Note that only approved site submissions are available to select. Sites are listed by the principal investigator's last name in alphabetical order. If all sites are affected, click the Select All Sites checkbox. If no sites are affected, don't select any sites and then click Save & Next to navigate to the next form.
4. Complete the additional forms that are displayed. Depending on your selections, you might also be required to upload additional documentation or a Tracked Changes copy of the most current IRB-approved ICF. Use the Save, Save & Previous, and Save & Next buttons to navigate between forms, enter requested information, and save your work. 
5. When you're finished and all required forms have been completed, click the Submit button.
6. In the window that appears, click the Submit Application button.

After it’s submitted, the modification will enter the Administrative Review status and you’re sent an acknowledgement email. You’ll be informed of next steps through notifications and updates to the submission.

Note that when you submit a Change of Principal Investigator modification, the site submission's name in CIRBI is updated to reflect the new principal investigator's name after the modification is approved by the IRB.

Prompt Reporting Events (PREs)

If unanticipated or adverse events occur throughout the life of the study, you might need to submit prompt reporting events (PREs) to the IRB. Each PRE you submit becomes a separate submission in CIRBI that’s processed by Advarra and is linked to the associated site or protocol submission. The IRB only reviews safety events (such as SAE, CIOMS, MEDWATCH, SUSAR, and IND Safety Reports) that meet the criteria of an Unanticipated Problems (UAP) Involving Risk to Human Subjects or Others or Unanticipated Adverse Device Effects (UADE). Refer to the IRB Handbook to determine if an event requires reporting to the IRB.

If you choose to submit a safety event that doesn’t meet these criteria, the IRB might not review these safety reports and will instead only provide an acknowledgement of receipt, which incurs a fee.

In CIRBI, you can create 6 different types of PREs from 5 different forms, depending on the reason for the report:

Non-Compliance Report

The Non-Compliance Report form allows you to submit a non-compliance report to the IRB. In the event of an instance or pattern of study non-compliance, you must submit a Non-Compliance Report for IRB review.

Protocol Type Considerations

Single-site protocols or site submissions: When you submit the Non-Compliance Report form for a single-site protocol submission or a site submission, the report is only applicable to that protocol or site submission.

Multi-site protocols: For multi-site protocols, the Non-Compliance Report form can be completed at the protocol level if it’s applicable to multiple or all affiliated sites. When you submit the Non-Compliance Report form for a multi-site protocol submission, you can choose the sites to which the report is applicable. If you choose to report the non-compliance at the protocol level and select all applicable sites, the sites do not need to submit their own non-compliance report at the site level.

To submit a non-compliance report, complete the following steps:

1. Click the Non-Compliance Report form.
2. On the page that opens, complete the forms that are displayed by answering questions about the study non-compliance. Make sure your descriptions of the event, how the non-compliance was discovered, outcome/resolution, and impact to participant safety are complete and accurate.
3. Upload any related documents to the Attachments section. We recommend you don’t provide unblinded documentation.
4. Click Save.
5. For multi-site protocols: The Principal Investigator Info form is displayed. On this form, select which sites were affected by this instance of non-compliance. If all sites were affected, click the Select All Sites checkbox. When you’ve made your selections, click Save.
6. Click Submit.
7. In the window that appears, click the checkbox to attest that you haven’t submitted unblinded documentation and then click the Submit Application button.

After it’s submitted, the report will enter the Administrative Review status and you’re sent an acknowledgement email. You’ll be informed of next steps through notifications and updates to the submission.

Audit Report

The Audit Report form allows you to submit the occurrence, findings, and corrective actions of an audit conducted by a regulatory authority during the study. If the study, site, or investigator is audited by a regulatory authority during the study, including for a study not under Advarra’s IRB purview, you must submit an audit report to the IRB.

Protocol Type Considerations

Single-site protocols or site submissions: When you submit the Audit Report form for a single-site protocol submission or a site submission, the report is only applicable to that protocol or site submission.

Multi-site protocols: Audit reports cannot be submitted at the protocol level; they must be submitted at the site level.

To complete an audit report, complete the following steps:

1. Click the Audit Report form.
2. On the form that opens, indicate the current enrollment status of the study and then click Save & Next.
3. The Audit Information form is displayed. This form lists all audits CIRBI has on file for the submission’s associated investigator and/or the investigational/research locations associated with the submission’s organization from the last five years.
   • To view details for an audit record, click the right arrow icon to the right of the record. In the right slider that opens, you can view the audit details and associated documents. To download a document, click the three dots icon and then click Download copy. To close the slider, click Close.
   • If the audit you want to report isn’t listed, you must add it as a new audit record. To add a new audit record, scroll to the bottom of the audit records list and click the Add button. In the right slider that opens, enter details about the audit such as the inspection type, dates, and finding. In the Related Documents section, you must upload the required audit-related documentation by clicking the Add Document button, uploading a file, and clicking Submit Document. Repeat for each required document. When you’re finished, click the OK button to save and continue, or click OK & Add Another to save this audit record and add another.
4. Click Save, and then click Submit.
5. In the window that appears, click the checkbox to attest that you haven’t submitted unblinded documentation and then click the Submit Application button.

After you submit the report, it will enter the Awaiting Assignment status and you’re sent an acknowledgement email, which you must retain for your study files. You’ll be informed of next steps through notifications and updates to the submission. 

Safety Event Report

The Safety Event Report form allows you to submit a safety event report to the IRB. In the event of an unanticipated problem that is likely related to study participation, that increases risks to subjects or other people, or that requires you to submit changes to the research or to the informed consent forms (ICFs), you must submit a safety event report to the IRB.

Depending on how you answer the lead-in questions to the Safety Event Report, the submission forms the system prompts you to complete are tailored to the type of event you’re reporting. When you submit this, one of the following submission types are created and linked to the protocol or site submission:

• Serious Adverse Event
• Unanticipated Problem
• Safety Report 

Protocol Type Considerations

Single-site protocols or sites submissions: When you submit the Safety Event Report form for a single-site protocol submission or a site submission, the report is only applicable to that protocol or site submission.

Multi-site protocols: For standard multi-site protocols, the Safety Event Report form can be completed at the protocol level if it’s applicable to one, multiple, or all affiliated sites. When you submit the Safety Event Report form for a multi-site protocol submission, you can choose the sites to which the report is applicable. If you choose to report the safety event at the protocol level and select all applicable sites, the sites do not need to submit their own safety event report at the site level. For Humanitarian Use Device multi-site protocols, you do not need to choose the sites to which the report is applicable.

To complete a safety event report, complete the following steps:

1. Click the Safety Event Report form.
2. In the window that appears, complete the lead-in questions about the safety event to the best of your ability. Depending on the answers you select, more questions might appear to request additional information.
   • If you respond Yes to all initial questions, an Unanticipated Problem submission will be created.
   • If you respond No to any of the initial questions, a new conditional question will be displayed to ask if the event occurred at your site.
     • If you respond No to the conditional question, a Safety Report submission will be created.
     • If you respond Yes to the conditional question, a Serious Adverse Event submission will be created.
3. Click OK. The submission forms page appears, and you can view your initial answers on the Safety Lead-In form. To continue to the next form, click Save & Next.
4. A second form related to the submission type that was determined in step 2 is displayed. Accurately and completely answer the questions about the event and its outcome to the best of your ability. This might include a description of the event and its outcome, the principal investigator’s rationale for the determination of the event’s relationship to the study drug or device, or the sponsor’s assessment of the event, depending on the type of event.
5. Upload any related documents to the Attachments section. We recommend you don’t provide unblinded documentation.
6. For single-site protocols and site submissions, click Save and skip to step 8. For multi-site protocols, click Save & Next and proceed to step 7.
7. The Principal Investigator Info form is displayed. On this form, select which sites were affected by this safety event. If all sites were affected, click the Select All Sites checkbox. When you’re finished, click Save.
8. Click Submit.
9. In the window that appears, click the checkbox to attest that you haven’t submitted unblinded documentation and then click the Submit Application button.

After you submit the report, it will enter the Awaiting Assignment status and you’re sent an acknowledgement email. You’ll be informed of next steps through notifications and updates to the submission.

If Advarra finds that the event doesn’t qualify as a serious adverse event or unanticipated problem, you’ll receive an acknowledgement email from CIRBI, which you must retain for your study files.

Deviation/Violation

The Deviation/Violation form allows you to submit a deviation or violation report to the IRB. In the event of a protocol deviation or violation, you must submit a deviation/violation report to the IRB.

Protocol Type Considerations

Single-site protocols or site submissions: When you submit the Deviation/Violation form for a single-site protocol submission or a site submission, the report is only applicable to that protocol or site submission.

Multi-site protocols: For standard multi-site protocols, the Deviation/Violation form can be completed at the protocol level if it’s applicable to one, multiple, or all affiliated sites. When you submit the Deviation/Violation form for a multi-site protocol submission, you can choose the sites to which the report is applicable. If you choose to report the deviation or violation at the protocol level and select all applicable sites, the sites do not need to submit their own deviation/violation report at the site level. For Humanitarian Use Device multi-site protocols, you do not need to choose the sites to which the report is applicable.

To complete a deviation/violation report, complete the following steps:

1. Click the Deviation/Violation form.
2. On the page that opens, answer questions about the current enrollment status of the study and the deviation or violation. Accurately and completely answer the questions about the event and its outcome to the best of your ability. You can optionally upload attachments in the Attachments section by clicking the Add Documents button. We recommend you don’t provide unblinded documentation.
3. For single-site protocols and site submissions, click Save and then skip to step 5. For multi-site protocols, click Save & Next and then proceed to step 4.
4. The Principal Investigator Info form is displayed. On this form, select which sites were affected by this deviation or violation. If all sites were affected, click the Select All Sites checkbox. When you’re finished, click Save.
5. Click Submit.
6. In the window that appears, click the checkbox to attest that you haven’t submitted unblinded documentation and then click the Submit Application button.

After you submit the report, it will enter the Awaiting Assignment status and you’re sent an acknowledgement email, which you must retain for your study files. You’ll be informed of next steps through notifications and updates to the submission.

Dose Escalation/DMC Report

The Dose Escalation/DMC Report form allows you to submit periodic reports of the safety and efficacy of the study. These reports can only be submitted at the protocol level for both single-site and multi-site protocols.

To complete a dose escalation or DMC report, complete the following steps:

1. Click the Dose Escalation/DMC Report form.
2. On the page that opens, answer questions about the current enrollment status of the study and the type of report you’re submitting. Accurately and completely answer the questions about the report to the best of your ability. If required, you can upload attachments in the documentation section by clicking the Add Documents button. We recommend you don’t provide unblinded documentation.
3. For single-site protocols and site submissions, click Save and then skip to step 5. For multi-site protocols, click Save & Next and then proceed to step 4.
4. The Principal Investigator Info form is displayed. On this form, select the sites for which the dose escalation or DMC is applicable. If it’s applicable to all sites, click the Select All Sites checkbox. When you’re finished, click Save.
5. Click Submit.
6. In the window that appears, click the checkbox to attest that you haven’t submitted unblinded documentation and then click the Submit Application button.