Instructions for Completion s2

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).

Version Date: September 2011 © Horizon Health Network – Ethics Services Page 1 of 4 Internal Working Document 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.

Version Date: September 2011 © Horizon Health Network – Ethics Services Page 2 of 4 Internal Working Document (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

Version Date: September 2011 © Horizon Health Network – Ethics Services Page 3 of 4 Internal Working Document 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.