UPDATED INVESTIGATOR’S BROCHURE (IB) / PRODUCT MONOGRAPH (PM)
Guidelines for Completing the Form
This brief guide will assist you to complete the Updated Investigator’s Brochure (IB) or Product
Monograph (PM) Form.
The information provided on this form is used by the Research Ethics Board to determine if
any change in the risk / benefit of the study has occurred, and to permit the REB to satisfy its
regulatory, ethical, and local obligations.
The ongoing safety and well-being of study participants is the primary concern of the Research
Ethics Board. For the REB to be in a position to provide ethical oversight to each study, they
must be kept informed of any updates to the Investigator’s Brochure or Product Monograph for
a study that the REB has approved and is monitoring.
It is the responsibility of the Local Principal Investigator to ensure that the information
contained in the Updated Investigator’s Brochure (IB) or Product Monograph (PM) Form is
accurate and complete.
The Updated Investigator’s Brochure (IB) or Product Monograph (PM) Form and attached
documents will be reviewed by a Primary Reviewer, and the form signed to document the
primary review.
The Primary Reviewer may contact the Principal Investigator or their designate if clarification is
required or if areas of the form are incomplete. The Primary Reviewer may enter data where it
is missing or make corrections to data (on the form) based on information in the REB file or the
research database. These entries will conform to the standard GCP requirements (GCP 4.9.3).
Please submit the following:
1 original completed Updated Investigator’s Brochure (IB) or Product Monograph (PM) Form.
1 copy of the summary of changes for the IB or PM.
1 copy of the IB or PM
Please keep documents that will require an REB signature separate from other documents
enclosed with your submission. (Do NOT staple documents requiring an REB signature to the
other enclosed documents).
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INSTRUCTIONS FOR COMPLETING THE FORM
Please note that unless an item is ‘not applicable’ for your study (which must be clearly indicated) ALL
sections must be completed.
When completing the form, please use the “tab” key when moving between data fields. If
this is not done the formatting of the document will be altered and some information will
become lost/hidden in the form. If you require assistance or have any questions, please
contact the Ethics Services.
1. Research Study / Protocol Information:
Study / Protocol Title (Full Title)
Enter the full title. Regulatory and administrative agencies and GCP require that the full title (as
it appears on the sponsor’s protocol or your study proposal) be used to reference each study.
Protocol Number
Enter the Protocol Number (if applicable). Original research (investigator initiated) and student
research may not have a study or protocol number, in which case indicate N/A (not applicable).
Current REB Approved Investigator’s Brochure/Product Monograph Version# / Version
Date
Enter the IB or PM Version Number (if applicable) and the IB or PM Version Date for the IB or
PM that is currently approved by the REB. All IBs and PMs should have at least a version date
to distinguish them from previous versions.
Principal Investigator
Enter the name of the Local Principal Investigator.
Horizon Health Network (HHN) File Number
Enter the File Number assigned by Ethics Services or Research Services to your study.
Note: This is a unique identifier for your study and MUST be entered on any documentation
submitted in relation to the study. This will ensure more efficient processing of the Updated
Investigator’s Brochure (IB) or Product Monograph (PM) Form.
If your study was submitted and approved by a Research Ethics Board other than Zone 2/Saint
John (prior to the convening of the Horizon Health Network REB on October 21, 2009) you will
not have an AHSC or Horizon Health Network File Number. You will have a File Number that
was assigned to the study by the REB that served your zone. This File Number will be
maintained for the complete duration of the study (closing and archiving). If this describes the
situation at your study site, please leave this field on the form blank. Your File Number will be
captured elsewhere on the Updated Investigator’s Brochure (IB) or Product Monograph (PM)
Form.
Telephone number
Enter the telephone number where the Local Principal Investigator (PI) can be reached. This
facilitates access to the Investigator should questions arise regarding the Local SUAE Report.
If your project has a Research Coordinator (RC) or Research Assistant (RA), Ethics Services
will contact them this person with any questions that arise unless otherwise instructed. Please
enter the PI telephone number only.
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(Non AHSC/HHN) Local File# / REB Zone City
This data field applies to those studies outside Zone-2, Saint John that were underway prior to
the operation of the Horizon Health Network REB (October 21, 2009).
Enter the File Number assigned to the study and the REB Zone City of record. (Moncton or
Fredericton)
2. Updated Information:
A “summary of changes” should accompany an updated IB or PM. Please ask the sponsor if
they have a “summary of changes“ document to accompany the IB or PM. This is particularly
important if the revised information changes the risk profile for study participants. On occasion
a “Summary of Changes” document does not exist for an updated Investigator’s
Brochure/Product Monograph.
2.1) Drug Name
Enter the Generic and (trade name) of the drug. (Both names may not be available, particularly
for drugs that are in early development and not approved by a regulatory agency)
2.2) Investigator Brochure?
Check the box that identifies the document type. A document containing the information
regarding a drug that has not received approval from a Regulatory Body (FDA or Health
Canada) is called an Investigator’s Brochure.
2.3) Product Monograph?
Check the box that identifies the document type. A document containing the information
regarding a drug that has received approval from a Regulatory Body (FDA or Health Canada)
is called a Product Monograph.
2.4) Publication version date
Enter the Publication Version Date of the document that has been submitted.
2.5) Edition number or Version number
Enter the Edition Number or Version Number of the document that has been submitted.
Product Monographs may not have this number, in which case, leave the data field on the form
blank.
3. Principal Investigator (PI) and Sponsor Statement and recommended action:
If the update to the Investigator’s Brochure or Product Monograph requires changes to the
Protocol or Informed Consent, please complete and submit an Amendment Form with the
accompanying documents to the REB.
3.1- 3.2) PI’s statement regarding changes to the protocol/Informed consent
The Principal Investigator is to indicate here if in their opinion there needs to be an amendment
to the protocol or informed consent as a result of the new information in the IB/PM.
Check the box that is applicable based on the opinion of the PI.
3.3) Sponsor’s statement regarding changes to the protocol/Informed consent
The Sponsor’s statement regarding the need for an amendment to the protocol or informed
consent as a result of the new information in the IB/PM is made here. The sponsor may not
provide you with this information. The Investigator may choose to make an inquiry to the
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sponsor to obtain a response or alternatively the Investigator may check on the form that no
comment has been given by the sponsor. Check the box that is applicable.
It is the responsibility of the Principal Investigator to ensure a copy of the updated
Investigator’s Brochure or Product Monograph has been forwarded to the Pharmacy
Department.
4. Identification:
Signature
The Local Principal Investigator must review the Updated Investigator’s Brochure (IB) or
Product Monograph (PM) Form, then print their name, sign, and date the form in the identified
spaces before submission to the Research Ethics Board.
The last section of the form (shaded area) provides information relating to the REB review of
the Updated Investigator’s Brochure (IB) or Product Monograph (PM) Form.
Shaded Areas (Investigator Research Coordinator/Assistant) Please Read
For use by the Research Ethics Board only.
This area of the form will be utilized by Ethics Services and the Research Ethics Board. The
Updated Investigator’s Brochure (IB) or Product Monograph (PM) Form will be reviewed and
acknowledged by a Primary Reviewer.
Additional information submitted by the Investigator regarding forthcoming changes to the
protocol or informed consent will be reviewed by the primary reviewer and may be reported at
the next meeting of the REB.
The original Updated Investigator’s Brochure (IB) or Product Monograph (PM) Form will be
returned to the Principal Investigator. A copy of the form and any accompanying
documentation will be retained for the study file.
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