Maximum number of subjects to be enrolled for entire protocol:
Total NIH CC Projected Ceiling: __________
Total non-NIH CC Projected Ceiling: __________
Total Projected Ceiling: _________
What should I enter for Z number if the project is extramural and has no Z number? The field is required, but it looks like entering Z in the field satisfies the validation.
This is a required field for the Inclusion of Women and Minorities in Clinical Research policy. They require that either the Z number (for intramural) or grant number (for extramural) be reported with the enrollment data. This data is collected by the Office of Protocol Services (OPS) in the CC and reported to NIH on behalf of the investigators in the Intramural Research Program. However, the database used by OPS currently does not accept a grant number. So for the time being, enter just the letter Z in this field.
There is a new question asking for the anticipated date of the completion of study analysis. What do I put when I do not know?
This is the estimated date of when the protocol data analysis will be completed and the study can be closed. For many of our studies, this could be many years in the future. Make your best guess. You will have a chance to update this date each time you complete a CR.
I have NIH collaborators on my trial. Where do I include them?
Any collaborators who have a NIH NED ID (including those who are “special volunteers” should be listed under the KSP section in iRIS. If a person is not an AI but is a collaborator or other Key Research Personnel, then list them in the “research support staff” section of the KSP and identify their role (either collaborator or other KRP).
I have non-NIH collaborators on my trial. Where do I include them?
When you create a revision to the application, you should add any non-NIH collaborators (that were not listed as AIs) at that time. You will not be able to add the people that are NIH collaborators or NIH “other key research personnel” until you do an amendment. This is because of how iRIS works; you cannot change the people under the KSP section until you do an amendment.
I'm not familiar with BTRIS. What is it? Who should have access? Are all Key Research Personnel allowed BTRIS access?
The Biomedical Translational Research Information System (BTRIS) is a resource available to the NIH intramural community that brings together clinical research data from the Clinical Center and other NIH Institutes and Centers. BTRIS provides clinical investigators with access to identifiable data for subjects on their own active protocols, while providing all NIH investigators with access to data without personal identifiers across all protocols. Data are available from 1976 to the present.
The BTRIS policy is not to provide people access to data from a particular protocol (or a patient on that protocol) unless the PI first “grants” them access.
There is a way for the PI to “grant access” through the application now. If your PI agrees, then check yes, that all KSP can have access to the data in BTRIS. If the PI does not want to give everyone access, list the people the PI does not want to give access to in the text box.
Here is the link to BTRIS if you want to learn more about it: http://btris.nih.gov/
How can I find out if my team has completed the required training?
You can search for the training records of all of your KRP on this webpage: https://federation.nih.gov/ohsr/nih/investigator-training.php and see what the required training is given the type of protocol/their role. If you can’t find evidence of their training on the OSHRP website, you will need to collect the training certificates from each AI and keep it in your regulatory file for the protocol as evidence of their training. Once you know that all the AIs and other KRP have completed their training, then you can “certify” that they have done so. If you cannot certify that all KSP have completed the training per SOP25 (found on: https://federation.nih.gov/ohsr/nih/pnp.php ), then please leave the checkbox blank and in the text box list the KSP that have not completed their training yet.
Where do I find SOP 25?
A: SOP 25 is not a NCI SOP, this is one of the new NIH IRP SOPs and can be found on their webpage: https://federation.nih.gov/ohsr/nih/pnp.php. You can also search for the training records of all of your KRP on this webpage: https://federation.nih.gov/ohsr/nih/investigator-training.php and see what the required training is given the type of protocol/their role.
How do I know if we are the coordinating center?
A: If you are the site that is aggregating the data for the protocol, and will be responsible for reporting that data, then you are the coordinating center. A coordinating center is the entity that is responsible for overall planning, document collection, monitoring and communication among all sites participating in a multi-site research project. A coordinating center may also be responsible for data management and analysis and may be designated either by a sponsor or by mutual agreement of the participating sites.
If your PI is contracting out the coordinating site then you (NCI) would be listed as the coordinating center. If you are sending data to a different party, then you would not be the coordinating center even if your PI is listed as the “lead PI.”
If this is a cooperative group study and another entity serves as the coordinating center for the cooperative group, the answer would be “no.”
For multi-center studies in which NCI is the coordinating center, you will need to enter information about each site including the FWA and IORG (IRB identifier) numbers. There is a link to search for these numbers provided within iRIS now and that link will open in a new tab.
I can’t find the IORG number and the site doesn’t know what their IORG number is either!
The IORG number is the IRB organization number and is in the same search area on the OHRP website, but there is a separate tab on the page for IORG numbers. The FWA and IORG numbers are not linked on the OHRP side, making them difficult to find. Try using the most minimal search term you can, such as a single word that is the name of the hospital/center e.g. “Georgetown.”
I have an old trial that originally was multi-center but is now only enrolling at the Clinical Center. Should it be listed as a single site study, filling out one cumulative enrollment form, since that is what it is currently?
If the NCI is responsible for the collection and reporting of the data then it is still a multi-site with only one enrollment site. Two cumulative enrollment forms should be submitted and the other sites listed as participating sites even though they are no longer enrolling subjects.
I’m working on an application for a multi-center study on which NCI is a participating site. I answered the question about the coordinating entity, but I’m not guided to anything that’s asking for the FWA #. Did I do something incorrectly?
If we are just a participating site, we do not need the FWA of the coordinating site. We need to provide FWA numbers of sites only when we are the coordinating center.
If we are a participating site, do we still put the non-NIH projected ceiling here? Or is that second question only applicable if we are the coordinating center?
Maximum number of subjects to be enrolled for entire protocol:
Total NIH CC Projected Ceiling: __________
Total non-NIH CC Projected Ceiling: __________
Total Projected Ceiling: _________
Only enter a number in that field if you are the coordinating center and enrolling subjects at site(s) outside of the Clinical Center. Otherwise enter zero.
On the IR form, we indicate the total projected ceiling at the CC, total projected ceiling for other sites, and total accrual ceiling. On the cumulative enrollment form, we say the accrual ceiling for each and the numbers enrolled. Since our projected numbers for each site may be guesstimates, if the projected numbers change over time, how can we update them?
This answer is pending.
What dates do I use for DEC submission when revising my study application?
When you are completing a revised application, and you are asked to fill out the date you submitted the PHF (DEC) form and it was cleared, please enter the dates of the most recent time you submitted a DEC form and it was cleared. If you are completing a CR, then use the date that you have submitted the DEC form for the CR you are submitting.
What is the “certification document” for COI that I am being asked to distribute?
This is part of the NIH IRP SOP 21, which has not yet been implemented across the IRP. Please check either “no” or “n/a” unless this new SOP is rolled out.
There is a new question that asks: “Has the Conflict of Interest Certification document been distributed to NIH employees, SGEs, and IPAs serving as Key Research Personnel (not listed as investigators)”? I'm not sure what SGE and IPA are.
SGE stands for “special governmental employee” and IPA stands for “Interagency personnel agreement.” These are separate status under which people can have federal positions who are not a regular employee. This is part of NIH IRP SOP 21, which has not yet been implemented across the IRP.
Does the money subjects receive for travel, hotel and food count as remuneration?
Check yes in this box only if subjects will receive remuneration for participation in a protocol (e.g. blood draw, PET scan). This does not include reimbursements for travel, meals, parking, etc.
Do I need to say that the NIH is the responsible party, even if my study is not an applicable clinical trial (ACT)?
Correct, please mark this field as “yes” unless this study has already been posted on http://www.clinicaltrials.gov/ by someone else. The NIH CC registers all protocols on http://www.clinicaltrials.gov/ ,even if the trial is not an ACT on behalf of the investigator.
Is it intentional that even if NIH is not the responsible party that we still have to fill out the info on outcomes, interventions, primary completion dates, etc.? The questions have asterisks, but I’m not sure we should be involved.
Even if we are not the responsible party, we still have to fill that out. If they study is already posted on http://www.clinicaltrials.gov/ , then you can use that information to complete our form.
Why am I asked to list citations?
http://www.clinicaltrials.gov/ lists up to 3 relevant citations for other people to see when searching for a study. This gives you an opportunity to specify up to 3 citations for http://www.clinicaltrials.gov/ that you would want others to reference . If you don’t specify, then no citations will be listed for your protocol on http://www.clinicaltrials.gov/ .
In the interventional studies section, I am asked to list the study interventions. What do I put here?
For the study interventions, list the interventions that are being performed as part of your primary study objective/endpoint. Do not include things that are being done as part of standard of care or supportive care in your study.
How to I specify the cohorts and arms in the protocol and in iRIS for CCR studies?
Cohorts and Arms should be used as defined in the protocol template. The tables should be inserted into all protocols, even if the study has only one cohort and one arm.
If the study has an outside sponsor, still include the tables in the protocol supplement and use our model to define the cohorts and arms, not necessarily what is listed in clinicaltrials.gov or in the protocol by the sponsor. This data will be used in CCR’s registration system for these types of studies. Please explain in the protocol supplement the purpose of including this information and clarify why it may be different than the sponsor protocol. For example: The Cohorts and Arms listed below have been modified using our model and do not exactly match the Sponsor’s description of Cohorts and Arms.
If an arm or cohort closes, do not delete it from the application or protocol. Mark it instead as “closed” at the end of the arm/cohort description.
Do not list comparison groups in iRIS at all. They should be specified in the protocol, but do not need to be in iRIS. These will be entered into clinicaltrials.gov at the completion of the study when the results are reported. Please see the link to the protocol modeling presentation for further explanation of arms, cohorts, and comparison groups.
Cohorts:
List cohorts as needed for registration of subjects at time of enrollment, not for analysis of comparison groups (that is done at the completion of the study when the results are entered into clinicaltrials.gov). Only list cohorts separately as needed to differentiate for enrollment, e.g. 20 patients with disease X and 20 patients with disease Y.
If a phase 1/2 study, then list each phase as a separate cohort.
If there is a lead-in phase or an expansion phase of a phase 1 or 2 study, then the lead-in phase (or expansion phase) should be listed as a separate cohort.
Note: Cohort should be assigned distinct names & have a unique description.
Arms:
For a standard phase 1 study, mark it as “sequential” but only list one arm (do not list each dose level as a separate arm).
If it is a phase 1/2 study, list each phase as a different arm.
If there is a lead-in phase or an expansion phase of a phase 1 or 2 study, then the lead-in phase (or expansion phase) should be listed as a separate arm.
In this case, cohort one (lead-in) would be assigned to arm 1 (lead-in) and cohort 2 (phase 2) would be assigned to arm 2 (phase 2 treatment).
Note: Arms should be assigned distinct names & have a unique description.
For complicated study designs, please consult with Seth Steinberg and/or Jason Levine for the correct assignments.
What is the primary completion date and how do I know what to put here?
This is the date that the final subject will be examined or an intervention received for the purposes of final collection of data for your primary outcome. For example, if your primary outcome is response rate, then the date that the last patient treated has their response to treatment evaluated would be your primary completion date. This date is important because one year from this date is when you will need to report the results of the study into http://www.clinicaltrials.gov/ if your study is an applicable clinical trial. You will have a chance to update this date each year when you do your CR, so take your best guesstimate for now.
There is a new question that asks “Are any of the children wards of a State or any other agency, institution, or entity”? I know we will take emancipated minors. But I'm not sure if we were faced with someone in, say, an orphanage that needed help via the protocol and was a ward of the state, etc… how we should answer this.
I would only answer yes to this if you PLAN to enroll children who are wards of the state, etc. in your protocol. (i.e. you are conducting your research in specifically in a population of children who are wards of the state).
How do I know what to put for the recruitment status on the initial review form?
A: If your protocol will be ready to enroll patients as soon as the IRB approves it and OPS completes processing the protocol, then select “open-recruiting.” If you know that there are outstanding approvals (e.g. FDA, CRADA) then select “not yet recruiting” and then later when all approvals are obtained you will submit a study status change form to the IRB via iRIS.
What if my protocol does not have a consent form and is a specimen or data/image analysis protocol?
For this type of study, you should select “no recruitment planned.” This way the protocol will not be listed on http://www.clinicaltrials.gov/ as a study that is recruiting or enrolling subjects.
FAQs for Continuing Review Submission Form
FAQs for Amendment Submission Form
FAQs for Planned and Cumulative Enrollment Forms
These pages will continue to be updated as more information becomes available.
Note: If you have a submission procedure question that isn’t answered within these pages, please contact: nciprotocolsupportoffice@mail.nih.gov