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Protocol Amendments and Revisions
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DEFINING MODIFICATIONS: CHANGES IN APPROVED RESEARCH 56.108(a)(4)

 

The IRB regulation has two similar but separate requirements related to study changes in approved research. One concerns changes in research and the other concerns changes in research activity.  This section addresses changes in research.

21 CFR 56.108 In order to fulfill the requirements of these regulations, each IRB shall . . .

(a) follow written procedures:

(3) for ensuring prompt reporting to the IRB of changes in research activity and;

(4) for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects."

 

Submitting Changes in Research to E&I

E&I offers a Request for Modification Form (Form 44A) to use when requesting approval of changes in research.  E&I will ask the submitter to identify the type of change as minor, or major upon submission.  All requests for modification must be received by the IRB in sufficient time to allow approval.

Major modifications:  design or goal change or anything that increases risk more than slightly needs full board approval.  Examples: recruitment materials, changes that reduce risk, changes in administrative nature such as address or phone number.

Minor modifications:  changes that reduce risk or increase it only slightly.  Minor changes in research typically qualify for review by expedited process.  Examples: recruitment materials, changes that reduce risk, changes in administrative nature such as address or phone number Addition of investigators or devices within protocols approved for such additions are minor modifications.

Note:  When E&I is serving as the central IRB for a multi-site study, the sponsor may be allowed to submit modifications on behalf of the individual investigators. In this instance however, E&I will either require that site-specific notifications of approval be sent by our administration, or we will require that each investigator submit a memo of intent prior to implementing the requested changes.  This requirement is to ensure that the investigator has seen the change and has agreed to implement it at that site.  

 

Submitting Site Related Changes to E&I

Although site related changes are considerd changes to the research, E&I has developed separate processes for processing these submissions.

Changes to Site Information

All changes to site-specific information must be reported to E&I in writing prior to their implementation.  When unforeseen changes occur, please provide written notification as soon as possible following the change.  For IND studies, E&I will require the site to provide an updated FDA Form 1572 reflecting the change.  If this updated version is available at the time of notification, the actual FDA Form 1572, as well as, site contact information (phone number, etc.) must be sent.  Common types of changes reported in this manner may include:

  • Change in Study Coordinator / Primary Contact
  • Change to site address / phone number / fax number / email address
  • Addition or removal of satellite location
  • Change to subject stipend

 

Changes to Principal Investigator

When there is a change to an existing Principal Investigator, E&I requires the new incoming Investigator to submit using the Principal Investigator submission process as outlined under “Investigator/Site" "Initial Submissions", including an updated FDA Form 1572 for IND studies.  The outgoing Investigator must submit a letter to E&I identifying their reason for leaving the study.


Last Updated ( Friday, 07 April 2017 11:57 )