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Official Documentation of Reliance

Nov 19, 2018

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This letter serves as documentation that Golden Gate Medical Center has agreed to rely on the Cambridge Pediatric Hospital IRB using the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement.

NOTE: This is not a notice of IRB approval. A separate email will be sent when the study is approved by the reviewing IRB.

Study Title: Longitudinal study of MMR vaccination in patients born from 1980-2018

Relying Site PI: Mark Jessup

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This is a Trial Innovation Network study.

Information about this study is available online at:
https://www.irbexchange.org/study/index/?proj=111

Sincerely,

The IREx Team

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Official Documentation of Reliance

Nov 19, 2018

# entry[].resource.section[].text.div
This letter serves as documentation that Golden Gate Medical Center has agreed to rely on the Cambridge Pediatric Hospital IRB using the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement.

NOTE: This is not a notice of IRB approval. A separate email will be sent when the study is approved by the reviewing IRB.

Study Title: Longitudinal study of MMR vaccination in patients born from 1980-2018

Relying Site PI: Mark Jessup

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This is a Trial Innovation Network study.

Information about this study is available online at:
https://www.irbexchange.org/study/index/?proj=111

Sincerely,

The IREx Team

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Allergies and adverse reactions Document

# entry[].resource.contained[].manufacturer
Abbott Vascular Instruments Deutschland GmbH

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.contained[].manufacturer
Abbott Vascular Instruments Deutschland GmbH

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.contained[].manufacturer
Abbott Vascular Instruments Deutschland GmbH

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.contained[].manufacturer
Abbott Vascular Instruments Deutschland GmbH

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.contained[].manufacturer
Abbott Vascular Instruments Deutschland GmbH

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.contained[].manufacturer
Abbott Vascular Instruments Deutschland GmbH

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.contained[].manufacturer
Abbott Vascular Instruments Deutschland GmbH

# entry[].resource.section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

# entry[].resource.section[].section[].code.coding[].display
Allergies and adverse reactions Document

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Determination Letter

This document was generated on January 25, 2019 at 6:29 PM UTC

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ID:1655
Last Updated by:Ann Mere on January 25, 2019 at 6:28 PM UTC
Overall PI:Corey Warren
Overall PI Home Institution:Cambridge Pediatric Hospital
Title of Research Study:Longitudinal study of MMR vaccination in patients born from 1980-2018

A determination has been made regarding your request, Application ID:1655 - Longitudinal study of MMR vaccination in patients born from 1980-2018. This decision applies only to the determination of IRB reliance, and does not reflect IRB approval of the research project itself. Approval for each relying site must be obtained from the Reviewing IRB (the IRB accepting the reliance of others) prior to initiating study activity at each site.

If you have questions, contact the Reviewing IRB to determine further required action.

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Reliance Determination

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Overall Principal Investigator:Corey Warren

Federal Wide Assurance (FWA): | &nbsp;FWA12345678
Point of contact: | &nbsp;Sarah Lee, slee@cambridgepeds.edu
Site Investigator | &nbsp;Corey Warren

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Reviewing IRB accepts review for:

Cambridge Pediatric Hospital

Federal Wide Assurance (FWA): | &nbsp;FWA12345678
Site Investigator | &nbsp;Corey Warren, corey_warren@cambridgepeds.edu

Golden Gate Medical Center

Federal Wide Assurance (FWA): | &nbsp;FWA7777777
Site Investigator | &nbsp;Mark Jessup, m_jessup@goldengate.edu

Ridgeview Health System

Federal Wide Assurance (FWA): | &nbsp;FWA788788
Site Investigator | &nbsp;Samantha Bard, sbard@ridgeview.net

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The following institutions will NOT rely upon the Reviewing IRB:

Approval for each must be obtained from the IRB for that site (or through other arrangement, as applicable) prior to initiating study activity at that site. Please consult the institution's Point of Contact for further instructions:

University of Southern Coast, Point of Contact: Claire Foy, ffoy@usc.tech

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Responsibilities

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The following information summarizes the responsibilities of the Overall Principal Investigator (PI) and the Site Investigators (SIs).

Responsibilities of Overall PI:

Provide Site Investigators with:

Copies of all IRB approval documents

Current approved versions of study documents, such as protocol, consent and authorization forms, recruitment materials, etc.

Notifications of all modifications, amendments, or changes to the protocol

Notification of any suspension or termination of protocol approval

Receive and forward to the Reviewing IRB any:

Unanticipated problems involving risk to subjects

Major deviations

Reports of noncompliance

Include in continuing review reports:

Information regarding subject recruitment

Progress report(s) from relying institution(s)

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Responsibilities of Site Investigators:

Comply with protocol, amendments, and recruitment procedures as applicable and approved by the Reviewing IRB

Obtain informed consent as specified by Reviewing IRB, as applicable

Submit to Overall PI any:

Unanticipated problems involving risk to subjects

Major deviations

Reports of noncompliance, subject injuries, and subject complaints

Information regarding local variations in study conduct, such as subject recruitment, as requested

Progress reports, including summary of all enrolled subjects, screen failures, minor deviations, and all other information needed for continuing review, as applicable and in a timely fashion

Conflicts of interest of Site Investigators and site research personnel

In the event of a suspension or termination, stop research activity as instructed by Overall PI

In the event of an audit, allow the Overall PI and designees from the Reviewing IRB access to research related records

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Please direct questions regarding this determination or your responsibilities as an Overall PI or SI to the Cambridge Pediatric Hospital Point of Contact: Sarah Lee, slee@cambridgepeds.edu.

Thank you.

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Physical findings of General status Narrative

# entry[].resource.section[].text.div
patient consulted for colour blindness

First aid is provided

Patient should practice more on computer

provided medicine for colour blindness

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Generated Narrative with Details

id: example-mixed

status: final

type: Neonatal perinatal medicine Discharge summary (Details : {LOINC code '78418-1' = 'Neonatal perinatal medicine Discharge summary', given as 'Neonatal perinatal medicine Discharge summary'})

category: Report (Details : {LOINC code 'LP173421-1' = 'Report', given as 'Report'})

date: 30/10/2018 4:56:04 PM

author: Harold Hippocrates, MD

title: Discharge Summary (Neonatal Service)

confidentiality: N

Attesters

- | Mode | Time | Party
* | legal | 04/01/2012 9:10:14 AM | Harold Hippocrates, MD

custodian: Good Health Clinic

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Neonatal perinatal medicine Discharge summary

# entry[].resource.section[].text.div
(snip)

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(snip)

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Physical findings of General status Narrative

# entry[].resource.section[].text.div
patient consulted for throat Cancer

Radiation has provided

Dietary supplements like fruits and vegetables, which are rich in phytochemicals

provided medicine for throat Cancer

# entry[].resource.category[].coding[].display
Physical findings of General status Narrative

# entry[].resource.section[].text.div
patient consulted for Diarrheal Diseases

First aid is provided

Patient should avoid oily food intake

provided medicine for Diarrheal Diseases

# entry[].resource.category[].coding[].display
Physical findings of General status Narrative

# entry[].resource.section[].text.div
patient consulted for Malaria

First aid is provided

Personal protection and the environmental management of mosquitoes are important in preventing illness

provided medicine for Malaria

# entry[].resource.category[].coding[].display
Physical findings of General status Narrative

# entry[].resource.section[].text.div
patient consulted for Headache

First aid is provided

provided medicine for Headache

# entry[].resource.category[].coding[].display
Physical findings of General status Narrative

# entry[].resource.section[].text.div
patient consulted for Headache

First aid is provided

provided medicine for Headache

# entry[].resource.category[].coding[].display
Physical findings of General status Narrative

# entry[].resource.section[].text.div
patient consulted for Diarrheal Diseases

First aid is provided

Patient should avoid oily food intake

provided medicine for Diarrheal Diseases

# entry[].resource.category[].coding[].display
Physical findings of General status Narrative

# entry[].resource.section[].text.div
patient consulted for Fever and infections

First aid is provided

Patient should stay away from junk food and should avoid drinking cold beverages

provided medicine for fever and infections