PTMS WILL PERMANENTLY CLOSE TO NEW SUBMISSIONS ON DECEMBER 20, 2018. WHEN USING CNS IRB GUIDANCE AND TEMPLATES, PLEASE REMEMBER THAT IRB SUBMISSIONS AFTER DECEMBER 24, 2018 WILL BE THROUGH IRIS.
This section covers documents needed for the Continuing Review (CR) of a protocol.
Please note, many of the documents listed below are not required for IRB review, but are required
by other NIH offices for different purposes before a protocol can be forwarded to the CC Office of Protocol Services and receive
final NIH approval.
The documents are listed here as a service to investigators and because the IRB assists investigators in assembling and submitting all
required documents to the Office of Protocol Services.
Continuing Reviews should be submitted 2 months prior to protocol expiration date.
For CR’s reviewed by the full IRB, the expiration date is 1 year (364 days) from date of the
IRB meeting at which the CR was approved (with or without stipulations). For expedited actions,
the expiration date is one year (364 days) from the date of IRB chair signature. If the CR (expedited
or full Board) is approved within 30 days before the expiration date, it may be possible to retain the same date
the following year as the expiration date.
IRB staff determines if a CR is eligible for expedited review based on regulatory guidance in
45 CFR 46.110.
Not all CR’s that meet the regulatory requirements that permit expedited review will be expedited. The final
determination of whether a CR will be expedited is made by the IRB Chair.
IRB staff pre-review all CR submissions for completeness and compliance.
The CR is scheduled for the next available IRB meeting of its assigned panel
only after pre-IRB review is complete. If the CR can be expedited under a regulatory category,
it will be forwarded to the IRB Chair or designee for their review.
For information on how to upload an attachment in PTMS, consider taking the PTMS training course,
or contact the PTMS liaison for PTMS-related questions.
The Continuing Review Application is required by NIH. The information on this form is utilized by several
NIH offices and for a variety of purposes.
The Continuing Review Application is completed via PTMS.
In PTMS, the form is labeled “CR Application”. It is important to make sure that the CR Application page is filled out
completely, accurately and consistent with other submitted documents. Failure to do so will delay the review process.
The CR application is self-explanatory. The Office of Human Subjects Research Protections (OHSRP) has created the
"NIH Intramural Clinical Protocol Application Glossary"
which contains instructions for completing the Continuing Review Application.
Directions for completing each field can also be found in PTMS by hovering the mouse over that field.
The Continuing Review Memo is required by the IRB. The information in the memo provides a summary
of activity on the protocol during the prior continuing review period, typically a year.
Continuing Review Memo template
can be downloaded from PTMS under "IRB Forms".
It is periodically updated to incorporate new regulatory reporting requirements, so it is important to
download the most current version of the memo at the time of continuing review each year.
The completed Continuing Review Memo must be uploaded to the action’s attachments page in PTMS under the "Memorandum of Progress" heading.
For CR submissions, the most recently IRB approved protocol document must be uploaded to the
action’s attachments page in PTMS under the “Protocol” heading. No revisions are allowed at the time of
continuing review, so no changes can be made from the previously approved version.
Assure that the document name has the protocol number and date and identifies it as the protocol.
For CR submissions, the most recently IRB approved PDF consent and/or assent forms should be uploaded
to the action’s attachments page in PTMS under the "Consent Form" heading. Those consent/assent forms are
located on the
No revisions are allowed at the time of continuing review. Assure that the document name has the protocol
number and date, and identifies it as the consent form. Assure that all approved consent forms and assent
forms are uploaded.
The Cumulative Inclusion
is required for all studies that meet the
NIH definition of Clinical Research.
It provides information on the race, ethnic, and gender distribution of participants accrued to a protocol.
A subject is accrued to a protocol if they have signed any consent form for the study.
An individual subject can only be accrued once. This form should account for all active and past participants,
as well as screen failures and drop outs.
The header of the form needs to be completed to provide information on the accrual ceiling,
the number of participants enrolled since the last continuing review, and the total number of
participants accrued since the study began. The breakdown of race, ethnicity and gender should
match the total number of participants accrued since the study began.
The numbers reflected on the inclusion enrollment report should correspond to those on the CR Application, the CR memo, and the protocol.
For multi-site studies, multiple Planned Enrollment Reports may need to be submitted. For a multi-site study in which the
NIH site is the coordinating site, a separate planned enrollment report must be submitted for each of the following:
1) NIH Site, 2) All Other Domestic Sites Combined, and 3) Foreign Sites Combined.
The completed Cumulative Inclusion Enrollment Report(s) must be uploaded to the action’s attachments page in PTMS
under the "Accrual Table" heading.
More information on reporting requirements, visit the
NIH Inclusion Policy Website.
requires that each PI complete required training appropriate to each study.
PI training needs to be documented in PTMS for each protocol. The PI's training
documentation should be uploaded into the action’s attachment page in PTMS under the "Other" heading.
SOP 25 also delineates the required training for investigators, key research personnel and others working on the protocol.
The PI is responsible for assuring and documenting completion of all required training by each individual before s/he can
work on the protocol. Documentation of training by those other than the PI does not need to be uploaded into PTMS.
For information regarding training requirements, see SOP 25,
or contact OHSRP.
A protocol which includes the use of an Investigational New Drug (IND) or use of device under an
Investigational Device Exemption (IDE) requires submission of the annual FDA report to the IRB.
The IRB may request other FDA-related documents for the study.
For submission, upload FDA documents to the action's attachments page in PTMS under the "FDA Documents" heading.
For questions regarding FDA regulated research, contact the FDA directly.
Links to FDA regulations:
A protocol which involves the use of radiation for research purposes will need to provide documentation of approval
from the Radiation Safety Committee (RSC). RSC Approval is generally granted for 3 years, so application to the RSC
Committee is required approximately every 3 years. The IRB will need the following documentation of RSC review and approval:
- Form NIH 88-23(a): Application for Authorization to Use Radiation in Research Involving Human Subjects
- RSC Approval Memo
- Any formal correspondence with RSC (e.g., RSC stipulations stemming from review and PI response to stipulations)
For questions regarding RSC review, contact the RSC directly. Information about the RSC review can be found on their
The IRB can review the submission prior to RSC approval.
The submission to the RSC can be prior to, concurrent with, or after IRB review.
If RSC approval is not documented first, the IRB approval will be contingent on RSC approval.
If the RSC requires changes, those changes will need to be submitted to the IRB for further review.
The IRB cannot provide final approval and submit the protocol to the Office of Protocol Services for processing
until RSC approval is in place.
For submission, upload RSC documents to the action’s attachment page under the
"Radiation Safety Documents" heading in PTMS.
Some protocol submissions must be cleared by the Institute Deputy Ethics Counselor (DEC).
The Institute Ethics Office conducts a review of the financial holdings of certain individuals
listed on the protocol to determine if they have any potential financial conflicts of interest for that protocol.
Investigators who have a potential conflict identified will be contacted by the DEC. The DEC will work with the PI
to resolve any actual or apparent conflict.
Whether or not a protocol requires DEC Clearance, depends on whether it is a "covered research protocol" as defined
The individuals whose financial holdings need to be reported to NIH and reviewed by the DEC are those defined as "covered individuals"
in the policy. The PI and covered individuals must submit forms for the DEC clearance process.
The forms are available from and submitted directly to the DEC office and are not in PTMS.
Once the DEC review is complete and any conflicts are resolved, the DEC office will provide documentation of clearance to the PI.
For more information on the DEC Clearance process:
Contact the Institutes
Documentation of DEC Clearance should be uploaded to the attachments page in PTMS in the "Conflict of Interest Documents"
section unless done automatically by the IC in PTMS.
This documentation is not required before the IRB can review the protocol, but is required before the IRB office can
submit the protocol to the Office of Protocol Services for final NIH approval.
The data and safety monitoring section of each protocol identifies whom will monitor the protocol, what will be monitored, and how often.
If the protocol identifies an independent entity such as a data and safety monitoring board or an independent medical monitor,
then all reports for the CR reporting period should be uploaded under "Data and Safety Monitoring" in PTMS.
If the protocol is a multi-site study, additional information is needed for IRB review, depending on the nature of the collaboration.
Multi-Site Study and NIH is the Coordinating Site:
Submit documentation of current IRB approval from each of the collaborating sites.
Multi-Site Study and NIH is NOT the Coordinating Site:
Submit documentation of IRB approval, the protocol and consent form(s) from only the lead site.
Other Collaborative Study:
Contact the IRB Office for study-specific information on required documentation,
which varies based on the nature of the collaboration.
To submit documentation for a multi-site study, upload the documents to the action's attachments page in PTMS under the "Other" heading.
All recruitment materials require IRB review before they can be used. CNS
IRB guidance on recruitment material requirements is available
and must be supported by information on their planned use in the
"recruitment" section of the protocol.
To submit recruitment material, upload the documents to the action’s attachments page in PTMS under the "Other" heading.
At times, an institute may require Scientific Review Committee approval for a continuing review.
As each Institute determines their own process for scientific review, the process varies between Institutes
(and sometimes between Branches within the same Institute).
Contact the Institute Clinical Director for information on the Scientific Review process.
For submission, the Scientific Review approval and supporting documentation are uploaded to the action's attachments
page in PTMS under the "Scientific Review Notice & Response" heading.
Quality Assurance Report
The Quality Assurance (QA) section of each protocol identifies who will perform the QA monitoring, what will be monitored, and how often. If your protocol underwent QA monitoring within the past year, then the monitoring report must be submitted.
The QA monitoring report should be uploaded to the action’s attachments page in PTMS under the "Other" heading.
In light of the Genomic Data Sharing (GDS) and Human Data Sharing policies along with greater
initiatives to pool information, the CNS IRB has been working toward facilitating the tracking
and reporting of shared data and samples. This effort has resulted in the creation of the
Data & Sample Sharing Spreadsheet (DSS).
With the adoption of the DSS, technology transfer agreements no longer need to be listed on the protocol face sheet or
in the body of the protocol. The presence of a technology transfer agreement can be indicated with a "yes" to that
question on the face sheet and a reference to the DSS appendix. The Technology Transfer section within the protocol
similarly can simply refer to the DSS as an appendix. Then, at the time of Continuing Review, the Investigator will
submit the DSS as an updated report on what data and samples were sent and received.
Investigators must still work with their Institute’s Tech Transfer Office to determine whether
agreements are needed PRIOR to the dissemination or receipt of data or samples.