Training In Protocols

Every well-designed clinical trial requires a protocol.

The study protocol can be viewed as a written agreement between the investigator, the participant, and the scientific community. The contents provide the background, specify the objectives, and describe the design and organization of the trial. Every detail explaining how the trial is carried out does not need to be included, provided that a comprehensive manual of procedures contains such information. The protocol serves as a document to assist communication among those working in the trial. It should also be made available to others upon request. Protocols are designed to guide the investigation, to maximise use of resources and to remove bias.

Investigator bias:

Investigator bias occurs when an investigator ignores or goes beyond any pre-specified plan and makes subjective decisions about which trials and outcome variables will get reported. Well written and standardised protocols when adhered to strictly, remove investigator bias even on multiple site trials.

Training

Anyone working on a research study, no matter their role, should receive comprehensive training on the study protocol and this should be documented in a training log, signed and dated by attendees. When amendments are made to the protocol, informed consent document or study tools, training to update study staff on these changes should be conducted.

There may in addition be specialised training conducted with those involved in specific aspects of the protocol e.g. Laboratory procedures, pharmacy procedures, qualitative data collection.

When conducting research with adolescents, special consideration should be given to making sure staff are well-trained in aspects of study conduct that may differ from adult studies

  • e.g. Consent and assent process, ethical-legal aspects, providing adolescent-friendly services as part of the research etc.

BY YOLISWA NTSEPE (MA, PhD)
ADOLESCENT PROGRAMMES MANAGER

UPDATED NOV 22, 2023

TABLE OF CONTENTS:

  1. why adolescents?
  2. where do adults fit in?
  3. research methods and designs
  4. ethical concerns with adolescents
  5. protocol development
  6. adolescent friendly site assessment
  7. adolescent peer supporters
  8. implementation frameworks
  9. standard operating procedures
  10. data collection
  11. dissemination

REFERENCES & ADDITIONAL RESOURCES: