Get to Know the Team
Publication
IMP Planning
Study Amendments
100

Name any 3 colleagues (Sr. CTM or below) from the UK/EU Office

Corinna, Nike, Sergio, Denise, Aude, Nathalie, Carla, Pilar, Rohan, Aicha, Maimoona, Amandeep, Patricia, Karishma, Afeez, Tony, Dipa, Chloe, Jyoti, Adam

100

Who is behind the LP Pub email?

Kim Long & Madelyn Kissel

100

Who is behind the #CSM Late Phase email?

Antonio Alvarez and Pawel Trybilo

100

What is one new requirement for Sponsors to provide for the review of amendments per Medical Affairs?

Cover letter from investigator

200

Name any 3 colleagues (Sr. CTM or below) from the Foster City Office

Polly, Melody, Marina, Karina, Manli, Brenda, Chisimdi, Celestine, Rich, Dina, Madelyn, Kim, Uzma, Priya, Miguel, Pranali, Abby, Andrea, MyTops, Melissa, Heidi, Renuka, Jun, Art

200

Where you can find the email template to submit a request for a placeholder or content review?

LP SharePoint Working Groups Tab > DataVision folder

200

What is required before you can make an initial shipment for a new study?

IRB/EC approval and executed contract

200

Who is responsible for FMV resolution with a sponsor during amendment reviews?

Clinical Operations

300

In the first edition of our LP newsletter, who said they can give a 30-minute presentation about tea trees?

Aude Firek

300

What is the typical review turnaround for abstracts per the standard contract language?

7 business days

300

When should you update the drug request tracker?

Prior to the first of each month

300

Who should be provided a copy of a revised protocol in the event that changes are made that impact safety reporting, or one or more Gilead products were added?

PVE Operations

400

In the second edition of our LP newsletter, who said they can give a 30-minute presentation about Tupac Shakur?

Melissa Machado

400

Who is currently working on the Global Publicaton Management Flow process?

Selin Hall and Antonio Llamas

400

How can you QC or track shipments that have been completed for studies?

GILDA Dashboard > DSR Tracker report

400

True/False: All amendments need to go through full MAST review

False

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