Review Process

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Investigator↔Sponsor Protocol Submission Due 14 days prior to committee meeting IRB review Approval Approved with modifications Deferred Disapproved Tabled/Suspension Result notification to Investigators and Sponsors Approval Ongoing Contract

Regular review

Every first, third and fourth Wednesdays of the month (deadline: 17:00, 2 weeks in advance of meeting).
This schedule is subject to change in unusual situations.

Proposals received after the deadline are carried over to the next meeting.

Rapid Reviews may be conducted outside of regular meeting times in appropriate circumstances.

Copies of the documents for submission

  • New proposal documents and progress review documents, six copies (including the original copy),
  • Additional review documents (modification forms, final reports, result reports, three PMS copies (including the original copy),
  • Original copy of SAE.

Review Fee for Application

  1. SIT/CROs, drug companies, medical device companies
    • Phases 1-4: application and review fee ₩500,000, Indirect cost 10%, hospital maintenance fee 5%,
    • PMS: application, review fee - 5% for total research fund, minimum ₩100,000 to maximum ₩500,000, indirect cost 10%, hospital maintenance fee 5%,
    • Complementary new review (trial): application and review fee ₩500,000, if the result of review is a "complementary new trial" or "Return",
    • Annual progress review: application and review fee is a total of ₩200,000 (application form from June 1st, 2011),
  2. IIT/ national research, multi-institute (conference, researcher leading) basic science
    • Phases 1-4: application and review fee ₩200,000,
    • Conference: application and review fee ₩200,000,
    • Complementary new review (trial): application and review fee ₩100,000, if the result of review is "complementary new trial" or "Return",
    • Annual progress review: if there is a fund provided, charge is ₩50,000 (application form from June 1, 2011). If there is no fund provided, it will be free of charge (application form from June 1, 2011),
    • If the application type is "researcher reading" and the fund is from a drug company, the review fee will be charged as for SITs,
    • Drug expenses,
    • General prescription, bundle, open-label research fees: 3%,
    • Double blind research, long-term date record research, specific drug prescription, general injection, power prescription fees: 4%,
    • Specific injection, complex prescription fees: 5%,
    • Drug expenses are computed in the clinical pharmacy. (tel : 240-2588).

Review Fee for Application

  1. Candidate Recruitment

    The researchers or sponsors recruitment notices or a call for applicants for the clinical trials on our popular website bulletin board. Mass media such as newspapers or broadcasting is also used when needed.

  2. Filling in the application form for clinical trial participation

    You can participate in clinical trials by applying on our website, by phone call to our center and in person.
    If recruitment has been filled for the clinical trial in which you applied, the center gives you priority at the next available opportunity.

  3. Informed written consent

    The applicants should visit the center at the appointed time and fill out the written consent form only after reading and understanding the information provided by the staff of the clinical trial center. For written consent, the information includes very important details such as the purpose and method of the clinical trial, the predicted effects, side effects and risks. You are also informed about alternative treatments for a current disease if you are a patient.
    First and foremost, this is to ensure that you are not getting any disadvantage from participation. Be aware that you can always withdraw your participation on a voluntary basis after your agreement at any time, and that you are eligible for compensation and treatment in cases following damage. You also receive guarantees of your personal status and your human rights.

  4. Preliminary inspection screening

    The preliminary inspection depends on the nature of the research and takes approximately 30 minutes. You have free access to your own results of the preliminary inspection. Participants should avoid rigorous exercise and alcohol consumption for 3 days in advance of the preliminary inspection.

  5. Research participation

    Subjects who are deemed suitable after preliminary inspection can participate in the study according to the research plan, and are administered with the newly developed medicine or control drug according to the specified time schedule. You may also be required to undergo clinical laboratory tests (or clinical examinations) similar to the preliminary inspection in order to check safety after drug delivery. Blood or urine collection may also be necessary to evaluate the effectiveness of drugs, with the total amount of blood collection always less than one unit of normal blood donation. Participants are compensated according to the terms of each study.

  6. Finalization of participation

    If nothing unusual is detected during the clinical trial process, clinical trial participation is finished after the planned period. In very rare cases, clinical trial participation can be discontinued according to the judgement of the researcher or the personal objection of subjects if there is significant abnormality or a severe abnormal allergy.