For participation in KNN, the research principal investigator and co-investigators from each hospital submit a written participation application form.
2. Review by the Executive Committee
The Executive Committee comprehensively evaluates the submitted participation applications from hospitals, considering conditions such as the number of patients, area distribution, NICU level, availability of personnel for data entry, and willingness to participate. The final approval for participation is determined based on this review.
3. IRB Approval and Consent Form Preparation
After approval from KNN, the research principal investigator at each hospital submits the necessary forms to their hospital's Institutional Review Board (IRB) to obtain approval. To ensure the quality of data entry, a commitment statement for diligent data input is submitted to KNN.
4. iCReaT Training and Certification
Research principal investigators and co-investigators receive certification after undergoing training on the iCReaT system, which is used for data entry in the e-CRF.
5. Completion of KNN Enrollment
Once enrolled, researchers can input patient data into the e-CRF, and they can receive necessary data for clinical care and research through the website's display program and annual reports.
Being KNN members have the following advantages in both clinical practice and research:
You can accumulate and preserve the key clinical parameters of your hospital using the secure national network server provided by KNN.
For each clinical parameter, real-time comparison of participating hospitals' current performance within the entire KNN network can be accessible on the KNN website. We also provide more reliable feedback data as a form of annual report by adjusting for associated risk factors for some major outcomes.
You can use the data as baseline data for Quality Improvement (QI) in clinical practice. KNN will contribute to nationwide standardization of clinical care through a program aimed at improving the quality of care through mutual exchange among NICUs in Korea.
Access to research opportunities using KNN data is possible upon submission of a research proposal and a commitment to diligent execution. This is especially beneficial for small volume centers where research may be challenging due to limited patient numbers.
Various forms of research are supported, including cross-sectional studies and retrospective studies using existing databases. In near future, we expect randomized clinical trials and multi-institutional research will be launched in the KNN.
KNN data adhere to internationally comparable item-specific standards, allowing for potential collaboration in international research with networks in countries such as the United States, Japan, Canada, and Australia.
Obligations of KNN Membership:
Research PIs and co-investigators must undergo certification after receiving training in the iCReaT system.
Research PIs must obtain approval from their hospital's Institutional Review Board (IRB) for KNN registered research and renew it as needed.
Research PIs are obligated to obtain informed consent from patient's parents according to IRB standards and maintain records of such consent.
Research PIs must actively encourage and diligently enter data for all eligible patients during the research period.
Research PIs are subject to audits of entered data. External audit team periodically visit member hospitals to assess the matching accuracy of medical records and entered data.
Research PIs must identify and correct errors in data entry and report them to the committee.
Research PIs are obligated to annually update data on the status of their NICU.