Transcript It`s Just a Little Change

IT’S JUST A LITTLE CHANGE;
OH AND IT’S TIME TO RENEW!
HOW TO SUBMIT AMENDMENTS AND RENEWALS
Human Investigation Committee
Human Research Protection Program
Yale University
 Federal
regulations and Yale University policy require
continuous approval of a research study
 When
the study’s approval period has expired, all
research activity must stop unless the HIC finds that it
is in the best interest of individual subjects to
continue
 Always
use the most recent Request for Renewal
form (Form5R), which can be found here:
http://www.yale.edu/hrpp/formstemplates/biomedical.html
 Submit
Form5R in addition to all supporting
documents (HIC application, consent forms, etc) 2
months prior to the lapse date
HOW MANY COPIES FOR PAPER SUBMISSION?
 General
rule is 2 x Form5R and 2 x documents
that need to be revalidated (protocol, consent
forms) and 1 x sponsor documents
 Once approved, recruitment materials, ROI
forms and HIPAA RAF forms do not need to be
submitted for renewal
 Refer to ‘HOW MANY COPIES’ document on the
HRPP website
WHAT ABOUT ELECTRONIC SUBMISSIONS?

Check Quick Guides on Coeus website

Submit only e-Form5R if other protocol documents are
approved electronically and live in Coeus

Once electronic, protocols stay electronic
TIPS FOR SUCCESSFUL RENEWAL
Fill out the entire form
 Do not copy and paste from previous year e.g. ‘Progress
of the study to date’ question
 Make sure the enrollment numbers are correct
 If subject enrollment has not progressed, explain why

WHEN IS AN AMENDMENT NECESSARY?

Any change to a protocol, consent form, or advertisement

If it’s a change, it’s an amendment
EXPEDITED AMENDMENTS
 An
Expedited Amendment is:
A proposed change in research related activities that does not
materially affect an assessment of the risks and benefits of the
study or does not substantially change the specific aims or
design of the study
 An
expedited amendment can be reviewed by a
regulatory reviewer in the office
 Examples:

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An increase or decrease in number of subjects targeted for enrollment
Change in the amount of subject payment
Grammatical changes/changes to sentences
Addition of recruitment materials
Change in Study Personnel
Minor clarifications of previously disclosed information
Other minor changes that do not affect the risk level
FULL COMMITTEE AMENDMENTS
A Full Committee Amendment is:
A proposed change in research-related activities that does materially affect
the assessment of the risks and benefits of the study or substantially
change the specific aims or design of the study

Full Committee amendments are reviewed at a Committee
meeting
 Examples:
Broadening the range of inclusion criteria
 Alterations in the dosage or route of administration of study drug
 Extending substantially the duration of exposure to the test material or
intervention
 The addition of serious unexpected adverse events or other significant
risks to the Informed Consent Document

CHANGE IN STUDY PERSONNEL
 Make
sure that the person to be added has HIPAA and
current HSPT training and COI disclosure on file
 Do
not submit protocol at the time of personnel
amendment
 Electronic
personnel amendments do not require
amendment forms in Attachments
 Remember
that personnel may not participate in study
activities without required training
CHANGE IN PRINCIPAL INVESTIGATOR
A
change in Principal Investigator requires a form called
Amendment to Change Principal Investigator


The form requires signatures of the outgoing and incoming PI AND
Department Chair
All documents must be updated to reflect the change in PI (e.g.
Protocol application, consent form, HIPAA RAF)
 Responsibility
to subjects:
Active participants in a study must be notified that there is a change in
PI
 Notification must be documented

What to include in the Amendment Request
Form
 Who
requested change: sponsor vs. PI
 What documents are affected
 The number of subjects that are enrolled and number
of subjects that are still receiving study intervention
 Whether the change affects risk to subjects
 Description of changes with RATIONALE behind them
 Page numbers and sections of the protocol/consent
forms/other documents where changes have occurred
 The
changes should be itemized in the form (one form
for multiple changes)
 Supporting
documentation should be provided e.g.
sponsor letter referencing the change, the IND report
 Changes
function
need to be indicated by using Track Change
How many copies for paper submission?

2 x amendment request forms

1 x documents with track changes

2 x clean documents that need HIC signature/stamp

1 x supporting documentation e.g. sponsor protocols, other
Committees’ approvals, etc.
What about electronic submissions?
 Check
Quick Guides on Coeus website
 The
general rule is to submit amendment request
form and any supporting documentation as NEW
documents in Attachments
 Documents
that are affected by the amendment
need to be saved on top of the previously approved
versions via AMEND button
 NO
changes can be implemented until reviewed and
approved by the HIC
 EXCEPTION:
An Investigator may make a modification to
research activities to avoid an immediate hazard to the
participant but must report this to the HIC within 10
working days
WHEN CAN AMENDMENTS BE SUBMITTED?
 Amendments
have to be submitted and approved
before changes are implemented
 Amendments can be submitted with reapproval
requests if happening at the same time (Renewal and
Amendment in Coeus)
 Amendments should be combined when possible
Note that if there is a pending amendment, you
cannot submit another amendment.
 We can’t approve an amendment request if the
protocol is not in approved status
CANCER CENTER AMENDMENTS
 Cancer
Center amendments cannot be accepted
without a PRC letter (either administrative memo of noneed for review or approval letter). Personnel
amendments no longer need PRC approval EXCEPT for
change of PI
 It
is necessary to thoroughly fill out the appropriate PRC
amendment request form, and provide the rationale
CONSENT ADDENDA

Consent addenda may be necessary to inform currently enrolled
subjects of new information, risks, or other changes that may
affect their decision to participate in the study
WHO TO CALL/EMAIL WITH QUESTIONS?

You can email us at [email protected] or [email protected]

You can call us at 785-4688

All inquiries are triaged to correct regulatory teams
QUESTIONS?
Thank you!