The following modules and background information have been designed to train all research staff who will be working on the PediCAP Study.

Courses: 

Protocol

Module 1: Background

Module 2: Participants

Module 3: Trial

Quiz*

If you have any questions contact Yasmine Yau (Project Manager)

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Child Pneumonia

Module 1: Background

Module 2: General Aspects

Module 3: Clinical Evaluation

Quiz*

If you have any questions contact Yasmine Yau (Project Manager)

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Microbiology Substudy

Module 1: Sample Collection and Management Manual Local laboratory procedures

Quiz*

If you have any questions concerning clinical trial management, clinical protocol and recruitment contact the Trial Management team

If you have any questions sample material, shipments, and sample collection and management, contact the below emails (Weekdays from 08:30 to 17:30 (GMT +1)

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Pharmacokinetic Sub-Studies

Module 1: Manual of Operations and Procedures

Quiz*

MRC Clinical Trials Unit

All correspondence: mrcctu.pedicap@ucl.ac.uk

Emily Dennis (Trial Manager)
Ben Spittle (Clinical Project Manager)

St George’s University of London

Dr. Julia Bielick (Trial physician)

University of Cape Town

Dr. Roeland Wasmann
Manna Semere Gebreyesus (trial managaer PK sub study)

ASI (LAB)

Dr. Hua Xu
Lewis Couchman
Stewart Hollington

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*Certificates are only available once a minimum of 80% is achieved in the final quiz for each module.

Site Initiation Visit (SIV) Resources*

  1. Protocol Training (.PDF)

  2. Screening, Consent and Randomisation (.PDF)

  3. Follow-up (.PDF)

  4. Oral stepdown and discharge (.PDF)

  5. Protocol Deviations, ISF and Monitoring (.PDF)

  6. Safety Reporting (.PDF)

  7. Pharmacy and IMP (.PDF)

  8. Data Management (.PDF)

     

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*Please do not share SIV PDF documents outside of the team.