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Posts tagged ‘Investigator Initiated Research’

Chapter #4 Part 1: Protocol Development

Assalamu`alaikum and greetings to all…

What do you expect from a degree holder nurse? At this moment, my answer would be patient’s care giver, educator, researcher and the list will be continued along with our years of experience in the nursing field. There are differences between protocol and proposal.

In protocol development, some of the questions that we have to answer are:

  • What is your study all about?
  • What you already know?
  • What we do not know?
  • Objectives of the study – keep it clear + specific + measurable + publishable
  • Method
  • How are you going to collect the data?
  • Expected results

In Clinical Research Centre (CRC), we will learn how to do Investigator Initiated Research (IIR) and Industrial Sponsored Research (ISR). In IIR, we have one Principal Investigator – yours truly.

  • Go to National Medical Research Register (NMRR) website and create a new account.
  • Submit your protocol under Investigator Initiated Research and follow the instruction.
  • Wait for approval from Medical Research and Ethics Committee (MREC)

Documents that need to be uploaded:

  • Cover letter to National Institute of Health (NIH)
  • Patient Information Sheet (PIS)
  • Informed Consent Form (ICF)
  • Curriculum Vitae (CV)
  • Protocol
  • Case Record Forms (CRFs) aka Questionnaires
  • IA-HOD-IA form
  • Good Clinical Practice (GCP) certificate

Remember, don’t be too ambitious!

Backward Translation + Forward Translation = Validation

Dan janganlah kamu berjalan di muka bumi ini dengan sombong, kerana sesungguhnya kamu sekali-kali tidak dapat menembusi bumi dan sekali-kali kamu tidak akan sampai setinggi gunung.

(Surah Al-Isra’ 17: 37)

Until we meet again.

May peace be upon you.

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