Technical Advisory Committee

Technical Advisory Committee (Members listed in alphabetical order)

Stephanie Dellicour, Pharmco-epidemiologist. Antimalarial Pregnancy Registry: Liverpool School of Tropical Medicine, Liverpool

Lew Holmes, Professor of Paediatrics, Harvard Medical School, Chief of Genetics and Teratology Unit, Massachusetts General Hospital, Boston and Director of North American Anti-epileptic Drug Pregnancy Registry

Linda Barlow-Mosha, Pediatrician and Senior Investigator at Makerere University-Johns Hopkins University Research Collaboration (MUJHU) in Kampala, Uganda.

Robert Pattinson, Director SAMRC/University of Pretoria Maternal and Infant Health Care Strategies Research Unit. Recently retired. Has been running the PPIP program.

Sthembiso Velaphi, Head: Paediatrics and Child Health Unit: Chris Hani Baragwanath Hospital

Dhelia Williamson, Statistician Epidemiologist: Maternal and Child Health Branch, Division of Global HIV/AIDS and TB, US Centers for Disease Control and Prevention, Atlanta

Rebecca Zash, Infectious Disease physician, Research associate at the Harvard TH Chan School of Public Health and the Botswana Harvard AIDS Institute Partnership.

UBOMI BUHLE: Understanding Birth Outcomes from Mothers and Infants, Building Healthcare by Linking Exposures: Pregnancy Exposure Registry Project

TECHNICAL ADVISORY COMMITTEE: TERMS OF REFERENCE

Purpose

The role of the technical advisory committee (TAC) is to provide scientific guidance to the Joint Project Team, ensuring scientific integrity of the work, guiding methods and ensuring robust analysis of data throughout the course of the project’s lifetime, while developing approaches that can be integrated into routine clinical care at registry sites with the intention of ensuring sustainability.

Specific Responsibilities

The specific responsibilities of the technical advisory committee include:

Advising on the design and development of the registry protocol and data collection tools
Provide guidance on data curation, management and analysis.
Review of all results and other outputs and guide on dissemination plans to ensure that results areinterpreted and reported accurately.
Identify funding opportunities, establish collaborative links with other relevant research and policynetworks and suggest potential additional sentinel sites for evaluation

Membership and Composition

Members of the TAC will comprise of the national and international experts in the field of pharmacoepidemiology, maternal and child health, HIV/AIDS, particularly PMTCT, birth defect surveillance, and teratology. The TAC meetings will be open to co-investigators and members of the birth defect review panel, to attend as observers who may be required to present during the meeting or provide any clarification needed.

The PIs will serve as executive members to present the proposed methodology, study progress as well as any emerging issues and results.

The Joint Project Team and the National Management Committee will be jointly responsible for selecting, appointing, and replacing all expert advisors on the TAC including rotation of the Chair as required.

Meetings, operational procedures and quorum

The TAC will convene 2-4 times a year either by teleconference or videoconference call. The meetings will take approximately half a day or less. The national project manager will be responsible for planning the meetings, preparing the agenda ( in consultation with the PIs, chair of the committee and technical oversight committee), taking minutes and circulating them to committee members and ensuring that a running list of action items is maintained. Approval of the minutes will be the first item on the agenda at the subsequent meeting of the Steering Committee.

The chair of the committee will be responsible for chairing the meeting, setting the agenda, keeping the discussions focussed and in time. Administrative support will be provided by the offices of the site. Any supporting documents for the meeting will be prepared by the project manager and sent out electronically no less than one week before the meeting date. The project manager will take written minutes of the meetings’ discussions and recommendations. These minutes will be reviewed and approved by the Committee at the next meeting of the TOC. Ad hoc meetings may be convened at the request of the project team members.

The committee will be considered quorate when at least two thirds of the committee members are present. Decisions will be made by consensus and any dissenting opinions will be recorded together with reasons. The site leads have the responsibility to accept, reject, or to modify TOC recommendations and implement these accordingly.

Communication

The project manager and/or the PIs will be responsible for communicating the recommendations and requests of the NMC to the TAC and vice versa as needed.

Version history

Version #	Implemented By	Revision Date	Approved By	Approval Date	Reason
1.1	Ushma Mehta	12 November 2020			N/A

Figures UB structure Feb23 - Structure

Figures UB structure Feb23 - Key