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DEFINITIONS

Please read carefully before fill up the form

refers to a pharmaceutical product that is being tested or researched in clinical trials, but has not yet been approved for marketing by regulatory authorities. IMP is experimental drugs or medications that are under investigation to determine its safety, efficacy and optimal dosage in treating specific medical conditions.

shall mean health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or an abnormal physical condition.

shall mean any placebo, or any substance taken by mouth, injected into a muscle, the skin, a blood vessel or a cavity of the body or applied to the skin to treat or prevent a disease, condition or symptom.

shall mean any person participating in a human clinical trial or research.

refers to a penalty or coercive measure imposed by one or more countries or international organizations against another country. In this context, the sanction refers to economic sanctions. As of September 2021, the countries facing economic sanctions or restrictions are Iran, North Korea, Russia, Syria, Venezuela, Myanmar and Cuba. Please refer to the official government sources to get the latest and updated information on sanctioned countries.

SECTION

Please read carefully before fill up the form

Kindly answer the questions below and furnish the necessary details and/or elaboration for our assessment.

Kindly upload all the files that we need according to the format stated below;

  1. Rename your file name as your full name
  2. Kindly use the PDF. format

1st question from this section is about inclusion. Question number 2 to 12 are for exclusion.

Kindly tick all the terms and conditions.

FORM

    Is the name stated in point no. 6 an UMMC staff?

    Does the person in point no. 6 hold an active C&P certificate?

    Is the person in point no. 6 APC certified?

    PDF copy of MREC application that includes MREC review/comments

    Research Protocol received

    Patient Information Sheet

    Informed Consent Form

    Is your research has any relation to ionising radiations or contamination by radioactivity from any nuclear fuel or from any nuclear waste from the combustion of nuclear fuel?
    YESNO

    Is your research related to any radioactive toxic explosive or other hazardous properties of any explosive nuclear assembly or nuclear component?
    YESNO

    Is your research arise from Hepatitis or any condition directly or indirectly caused by or associated with Human T-Cell Lymphotropic Virus Type iii (HTLV iii) or Lymphadenopathy Associated Virus (LAV) or the mutants derivatives or variations thereof?
    YESNO

    Is your research related to Acquired Immune Deficiency Syndrome or any syndrome/condition of a similar kind howsoever it may be named?
    YESNO

    Is your research associated with Transmissible Spongiform Encephalopathy (TSE) Creutzfeldt-Jakob Disease (CJD) variant Creautzfeldt-Jakob Disease (vCJD) or new variant Creutzfeldt-Jakob Disease (nvCJD)?
    YESNO

    Will your research expose UMMC to any sanction, prohibition or restriction under United Nations resolutions or the trade or economic sanctions, laws or regulations of the European Union, United Kingdom or United States of America?
    YESNO

    Is your research involving recruitment of any pregnant research subjects?
    YESNO

    Does your research involve the research, investigation, treatment and/or study into the fertility or pregnancy of a research subject?
    YESNO

    Does your research involve the research, investigation, treatment and/or study of a fetus in utero?
    YESNO

    Does your research involve the recruitment of research subject under the age of five (5) years at the time of research?
    YESNO

    Does your research involve any Covid-19 clinical trial of an investigational medicinal product?
    YESNO

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