HIV/AIDS Protocol Registration Frequently Asked Questions

This section provides answers to frequently asked questions (FAQs) regarding
DAIDS requirements for Protocol Registration Policy.

Q. What does "supported by NIAID/DAIDS" mean? Does it mean financially
supported?

A. In addition to financial support, “supported” also means direct and
indirect funding, other types of tangible support, such as providing lab
or data management services, regulatory support, study drug supply for research
activities. See the DAIDS glossary for
definition of “DAIDS supported.”

Q. For studies that are supported by DAIDS but DAIDS is not the IND
sponsor, are there different requirements for protocol registration?

A. Sites participating in studies where DAIDS is not the IND sponsor
will be required to submit the same documents to the DAIDS Protocol Registration
Office (PRO) as studies where DAIDS is the IND sponsor. The Protocol Registration
algorithm defines the protocol registration requirements when DAIDS does
not hold the IND but provides funding. See the algorithm associated
with the Protocol Registration Policy for additional details.

Q. Is a network expected to do protocol registration when the DAIDS
PRO doesn't? Is this still called Modified Protocol Registration?

A. DAIDS does not require networks to review site-specific informed consent
forms (ICFs) when DAIDS does not. However, DAIDS requires protocol registration
for all clinical research supported and/or sponsored
by DAIDS and reviewed by DAIDS Scientific Review Committees, namely the
Prevention Sciences Review Committee (PSRC) and the Clinical Sciences Review
Committee (CSRC). There is no longer a modified protocol registration process.

Q. What should network sites do if they have network requirements in
addition to what is required by DAIDS for protocol registration?

A. In general, it is recommended that if the networks/other groups have
additional requirements for their studies, networks/other groups should
develop guidance documents clearly stating the requirements sites must follow
in addition to the DAIDS requirements.

Q. I'm the new Study Coordinator at my site. Could you please update
the DAIDS Protocol Registration System (DPRS) so I start receiving all the
necessary communications/reports?

A. Sites and new personnel should contact their DAIDS Office for Clinical
Site Oversight (OCSO) representative or DAIDS program officer to initiate
this process.

Q. Can my submission be expedited?

A. If you need a submission expedited, please send an email to the DAIDS
PRO requesting an expedited review and the reason an expedited review is
required. A determination will be made by DAIDS on a case-by-case basis.​

Q. How should names be listed on the Form FDA 1572/DAIDS IoR Form?

A. Sites should use the complete legal name (full first and last name)
on all documents. It is recommended that site use the name that appears
on legal documents (e.g., medical license, passport) on all documents.

Q. Where should sites keep original Form FDA 1572s/DAIDS IoR Forms?

A. All originals should be maintained in the regulatory files at the
site.

Q. Can sub-investigators who are listed on the Form FDA 1572/DAIDS IoR
Form sign the DAIDS Protocol Registration Translation Confirmation Form
if the IoR is traveling and not available?

A. It is acceptable for a sub-IoR to sign the DAIDS Protocol Registration
Translation Confirmation Form if this duty is delegated to a sub-IoR by
the IoR.

Q. Although FDA does not require an immediate change to the Form FDA
1572 if a sub-investigator leaves the site, DAIDS does. Does that mean I
still need to update the Form FDA 1572 immediately?

A. If there is any major change to the information on the current Form
FDA 1572 or DAIDS IoR Form, a revised Form FDA 1572/DAIDS IoR Form must
be submitted to the DAIDS PRO within 30 calendar days.

Q. Should the box marked “Curriculum Vitae” be checked always or only
if CV provided for initial registration and when updated?

A. Sites should check the box if the IoR’s CV has been submitted to the
DAIDS PRO with a registration submission.

Q. What if an RE/Approving Entity only reviews and approves the initial
version of a protocol? Should the RE/Approving Entity be listed on the Form
FDA 1572/DAIDS IoR Form? What should I do when amendments are submitted?

A. The Form FDA 1572/DAIDS IoR Form must list all IRBs/ECs/REs/Approving
Entity(ies) that are responsible for the review and approval of a clinical
trial at a CRS prior to the CRS initiation of the protocol. If a RE/Approving
Entity is not responsible for the review of full version amendments, letters
of amendment or changes to the CRS site-specific ICFs, the CRS Leader or
IoR should document the IRB/EC/RE/Approving Entity procedures with a memo
to the DAIDS PRO or in the DPRS when submitting registration materials.

Q. If a site submits materials stating that their local IRB approval
is being performed by another IRB, does the local IRB/EC that is waiving
approval need to be listed on the Form FDA 1572/DAIDS IoR Form?

A. No. The site should list only the IRB/EC that responsibilities have
been delegated to on the Form FDA 1572/DAIDS IoR Form.

Q. Our main clinical site has an additional/alternate location where
participants will be seen by the same study staff from the main site; should
we list the name and address of both locations on the Form FDA 1572/DAIDS
IoR Form?

A. Per the DAIDS Protocol Registration Manual, sites must list the names
and addresses of all locations where the clinical
trial will be conducted. This includes all facilities
where participants will be seen and study procedures performed.​

Q. Since CVs are not protocol specific, do sites have to upload it for
each protocol or can it be stored in a cross-protocol manner on the DPRS?

A. Sites do not have to submit a new CV for each submission to the DAIDS
PRO as long as the CV on file has a signature and date that is less than
two years old.

Q. How will "expired" or "expiring" CVs be tracked, and who is responsible
for obtaining renewals?

A. The DPRS will generate a report and sites will be alerted when the
two-year expiration date approaches.​

Q. The Manual states that once a CRS has received approval from their
IRB/EC and other applicable REs/Approving Entities, the amended protocol
or LoA, and revised site informed consent(s) must be implemented immediately.
Can you clarify what is meant by immediately? Is there a window/grace period
for things such as administrative tasks or starting to have new consents
signed?

A. DAIDS expects that after receiving final approval from all IRBs/ECs/REs/Approving
Entity(ies), the CRS will implement approved modifications to the protocol
immediately, unless the amendment or LoA states otherwise. Refer to the
DAIDS Protocol Registration Manual for additional information regarding
amendment and LoA implementation requirements.

Q. The DAIDS Protocol Registration policy says that sites must submit
IRB/EC approvals for amendments and LOAs within 14 calendar days of final
approval. Our studies are reviewed by multiple IRBs/ECs. Does the 14 days
begin after receiving final approval from the ALL IRBs/ECs? Can we begin
counting the 14 days beginning with the date received? Will holidays count
in the 14 calendar days?

A. The 14 calendar days begin after receipt of the final written IRB/EC/RE/Approving
Entity approvals from ALLIRBs/EC/RE/Approving Entities.
Per the DAIDS Policy, the 14 calendar begins with the date the written documentation
of ALL IRB/EC/RE/Approving Entity approvals was received by the site. Holidays
will NOT be counted in the calendar days.

Q. Does the 45/75 day requirement to submit LoAs or full version protocol
amendments to the local IRB/EC apply when a site is not yet registered to
the study?

A. No. The requirement to submit an amended protocol is for sites that
have received initial approval for a previous version from their local IRB/EC.
Based on the DAIDS Protocol Registration Policy, the 45/75 day requirement
is not dependent on whether a site is registered to a study but rather it
is based on the date that the amendment or LoA was approved by DAIDS and
distributed to sites. This does not mean that the approved amendment or
LoA must be submitted and registered by the DAIDS PRO within 45/75 days.
The 45/75 day requirement is the timeline for submission to the local IRB/EC
only.

Q. How should sites handle protocol amendments for sub-studies? When
sites submit an amendment to the DAIDS PRO for the main study, should they
also submit a separate registration for the sub-study or is the approval
for the sub-study assumed to be grandfathered in the parent study amendment
approval?

A. Any protocol amendment (for the main study or sub-study) must be submitted
as individual (separate) registration. Individual registration submission
is also required for all LoA registrations.

Q. Can you provide clarification regarding the registration requirement
for Continuing/Annual Reviews? Are sites required to submit IRB/EC approval
of Continuing/Annual Reviews to the DAIDS PRO?

A. Sites are required to submit continuing review documentation to the
DAIDS PRO within 14 calendar days after the receipt of final written documentation
of IRB/EC approval.

Q. I've received a Registration with Required Corrections (RwRC) notification.
Can I start using the site specific ICFs or do I have to wait until the
required corrections are made and approved by the IRB/EC?

A. A RwRC Notification indicates that a site may begin using the site-specific
ICFs after protocol activation by the appropriate Operations Center, Data
Management/Statistical Center or DAIDS Program, if required. However, the
site must make the required corrections and submit them to their IRB/EC
for review and approval OR must submit justification
for why the required corrections will not be made within 120 calendar days
of the date the RwRC Notification was issued to the DAIDS PRO.

Q. I have already received a protocol registration notification for
my English site-specific ICFs for the current version of protocol xxxx,
but I just submitted revised English site-specific ICFs. Will I receive
a new registration notification?

A. No, the DAIDS PRO only issues one registration notification per version/language.
However, the DAIDS PRO will issue acknowledgement of receipt for the revised
site-specific ICFs.

Q. I've received a disapproval notification, but I do not agree with
the requested changes. What do I do?

A. If you would like DAIDS to reconsider disapproval, please submit a
disapproval reversal request to the DAIDS PRO. Additional information on
submitting a disapproval reversal can be found in section VI. C. ii of the
DAIDS Protocol Registration Manual.​

Q. Is there a specific format or template for the written documentation
sites must provide when a site deletes or makes any substantive change to
basic and/or additional elements as presented in the DAIDS-approved sample
informed consent (SIC)?

A. There is no specific format or template. Examples of written documentation
include but are not limited to the following:

  • A memo from the Investigator of Record (IoR) or designee
  • A copy of the submission letter from the site to the IRB/EC detailing
    the changes to the site-specific ICFs
  • A copy of the letter(s) from the IRB/EC documenting queries and
    changes required to the site-specific ICFs

Q. Can you provide examples of “substantive change to basic and/or additional
elements?”

A. Examples of these changes may include but are not limited to: deleting
risks, deleting sections that are in the DAIDS-approved SIC, stating that
there is compensation for research-related injury when the DAIDS-approved
SIC states that there is none.

Q. What if my IRB/EC requires language in the DAIDS-approved SIC to
be removed or requires language to be added to our site-specific ICFs?

A. Sites should provide a copy of the documentation from the IRB/EC requesting
changes to the site-specific ICFs and/or DAIDS-approved SIC. This documentation
should be provided with the site’s protocol registration submission to avoid
delays or disapproval.

Q. What if there is a pregnancy consent included in the DAIDS-approved
SIC, but my site only enrolls men. Am I required to submit a pregnancy consent?

A. No, only site-specific ICFs that will be used at the site are required
to be submitted to the DAIDS PRO. However, the site should provide documentation
stating that the ICF will not be used and why with the protocol registration
submission to avoid delays or a disapproval.

Q. If my site develops a long form and concise form and we only plan
to utilize the concise form, am I required to submit to submit both to the
DAIDS PRO?

A. Yes, the long form and concise form should be submitted for DAIDS
PRO review.​

Q. What does the term “REs/Approving Entity” include?

A. Any group other than the local IRB/EC who is responsible for reviewing
and/or approving a clinical research protocol and site-specific ICFs prior
to implementation at a site. Refer to the Definition section of the Protocol
Registration Manual for additional details.

Q. What type of documentation will be accepted as proof of IRB/EC submission
within 45 days?

A. Examples of appropriate documentation of the date an amended protocol/LoA
and any revised site-specific ICFs were submitted to the local IRB/EC include
but is not limited to

  • The submission letter from the site to the IRB/EC
  • A memo from the IoR or designee specifying the date of submission
    to the IRB/EC

Q. Are IBC approvals required for Amendments and LoAs?

A. IBC approvals for LoAs and amendments may or may not be required.
If an IBC must review and approve all full version protocol amendments and
LoAs prior to the implementation at a CRS, documentation of the IBC approval
should be submitted to the DAIDS PRO at the time of amendment or LoA registration.​

Q. If a RE/Approving Entity is not responsible for the review and approval
of full version protocol amendments, LoAs, or continuing/annual reviews,
will each submission for the same protocol and site require a separate statement
in the comments section of the DPRS?

A. No. This is a onetime requirement per protocol/site. If documentation
is submitted with the initial registration or with the first full version
protocol amendment registration, the site does not need to submit documentation
for any subsequent registrations for that protocol. However, if the local
regulations change, the IoR for the trial is responsible for ensuring that
DAIDS is aware of these changes.​

Q. Will time requirements for documentation submitted to the Institutional
Review Board (IRB)/ Ethics Committee (EC) also apply for consents that must
be translated into other languages as well?

A. Sites should submit the amended protocol and all the amended site-specific
ICF(s) to their IRBs/ECs and other applicable REs/Approving Entity(ies)
for review and approval as soon as possible. Per the DAIDS Protocol Registration
policy, submission to the local IRB/EC must take place within 45 calendar
days for U.S. sites and 75 calendar days for non-U.S. sites of the date
the amendment was approved by DAIDS and distributed to the sites.

Q. At our site we will enroll English- and French-speaking subjects.
Do we need to submit a back translation of the French ICFs?

A. No, if you have an IRB/EC-approved English site-specific ICF, you
are not required by DAIDS to submit a back translation of the French site-specific
ICF. However, some networks require back translations for all local language
site-specific ICFs.

Q. What if my network requires a back translation even though we have
an IRB/EC approved English site-specific ICF and DAIDS does not require
a back translation?

A. You should comply with your network’s requirements regarding back
translation.

Q. My site only consents participants in languages other than English.
Is a back translation for each language required?

A. Yes, if there is no IRB/EC approved English site-specific ICF then
a back translation is required for all other languages (with the exception
of Spanish).

Q. I have already been approved for my English site-specific ICF and
the IRB/EC just approved my local language site-specific ICF. Do I need
to receive protocol registration notification for additional languages?

A. Yes, all site-specific ICFs in all languages are required to be submitted
to the DAIDS PRO and a registration notification must be received prior
to utilizing the ICF.

Q. Is a back translation for Spanish site-specific ICFs required?

A. No. However, if your network requires a back translation you should
comply with your network’s requirements. A Translation Confirmation Document
is NOT required for all Spanish site-specific
ICFs.​

Q. When is the latest point at which a site should complete deregistration?

A. Although deregistration can take place earlier, the latest that a
site should deregister is after the primary analysis of the study is complete.

Q. How do we know when the primary analysis is done?

A. Sites may inquire with the protocol team.

Q. Can a site deregister if the protocol is still open at the IRB/EC?

A. Yes, after consulting with the IRB/EC, the site may deregister if
all participants are off study or protocol is closed to follow up. Protocol
specific safety documents will not be sent to the site. However, the monthly
safety distribution report can be found on the RSC website.

Q. Will we need to file for continuing/annual review if the study is
closed at the IRB/EC?

A. If a CRS closes a protocol with the IRB/EC, then it is not required
to submit continuing review to the IRB/EC. If the CRS did not close the
protocol with the IRB/EC then the CRS is required to submit continuing/annual
review. If the CRS has not closed with the IRB/EC but has deregistered with
DAIDS, the CRS does not have to submit the documentation of continuing/annual
review to the DAIDS PRO but must keep it in CRS’ regulatory files at the
site.

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