For information on the procedures for using the P-MICS DB, please see below.
1.Procedures for using the P-MICS DB
(1) Application for P-MICS DB Usage
The P-MICS DB secretariat initiated the operation of the Trial Use on January 1, 2021.
Please refer to the "Guidelines for Usage of Medical Information in the Pediatric Medical Information Collection System (Trial Use Period), Version 2 " for the documents to be submitted. Please obtain the forms to be used in the procedures of each process from the table in "(2) Flow of P-MICS DB Usage".
(2) Flow of P-MICS DB Usage (Researchers belonging to the NCCHD)
| Procedures | Summaries | Forms (as of September 20, 2022) |
|---|---|---|
| Preliminary Consultation (before Application) | Consultation will be conducted on the feasibility of your research within the scope of the basic information for users provided by the secretariat. | |
| Submission of Application for P-MICS DB Usage | To request P-MICS DB use, please submit an Application for P-MICS DB Usage (Form 1) for each unit of usage application to the secretariat. | |
| Review of Application for P-MICS DB Usage | When an application for P-MICS DB usage is submitted, the Chief Operations Officer (COO, i.e., Chairperson of the NCCHD) will review the application for P-MICS DB usage based on the criteria. In reviewing the application, the COO should, in principle, seek the opinions of the Expert Review Committee. The COO will decide whether or not to approve the application for P-MICS DB usage based on the results of the opinions of the Expert Review Committee. The secretariat will notify the applicant in written form on the results of the review regarding the approval or disapproval of P-MICS DB usage. | |
| Receiving Results of the Application Review | The secretariat will notify the applicant about the results of the Review of P-MICS DB Usage (Form 2). | |
| (Only if changes are made to the usage plan) | ||
| Submission of Analysis Plan | After signing the contract for use, the contractor is required to submit an analysis plan to the secretariat. The database user will execute the analysis by remote access to the P-MICS DB from a designated computer terminal in the statistical analysis area, following the analysis plan. |
|
| Submission of Application for Statistical Information Transfer | After the analysis is finished, the database user will organize the statistical information to be transferred outside the statistical analysis area. The contractor of the P-MICS DB usage should fill in the blanks of the Application for Statistical Information Transfer of P-MICS DB Usage (Form 6), and submit it to the head of the secretariat. The head of the secretariat will check the Application for Statistical Information Transfer of P-MICS DB Usage (Form 6) and the statistical information and any other information stored in the statistical analysis area, and then decide whether the statistical and other information can be transferred. If the head of the secretariat determines that the statistical information transfer is acceptable, the database user shall transfer the statistical information and the analysis report created using the statistical information from the designated computer terminal to the outside, and submit it to the secretariat. |
|
| Receiving Analysis Results | The secretariat prepares statistical information and analysis reports on storage media with security functions or read-only storage media, and notifies the contractor of the delivery of the analysis reports. At the time of delivery, the Agreement on Statistical Information Transfer for P-MICS DB Usage will be exchanged as a proof of the delivery of the recording media with security functions or read-only storage media. | |
| Submission of Application for Publication | The contractor should submit an application to the secretariat with the materials to be publicized, clearly indicating the correspondence with the approved use and the desired response period regarding approval or disapproval of the publication. The COO should seek the opinion of the Expert Review Committee on the applicability of the publication criteria to the material to be publicized. |
|
| Receiving Results of Publication Review | The COO decides whether or not to allow the materials to be publicized based on the opinions of the Expert Review Committee, and the secretariat communicates the decision to the Liaison Representative. | |
| Report on Publication of the Usage | The publicized material should clearly indicate that it is the result of P-MICS DB usage, and the contractor should report the summary of the achievements, including the publication media, to the secretariat promptly after the publication, using Form 11, Report on Achievements of P-MICS DB Usage. | |
| Submission of Final Report on the Usage | The Contractor must submit the Final Report on P-MICS DB Usage (Form 12) to the secretariat by the end of the contract period. |
(3) Flow of the P-MICS DB Use (Researchers not belonging to the NCCHD)
| Procedures | Summaries | Forms (as of September 20, 2022) |
|---|---|---|
| Preliminary Consultation (before Application) | Consultation will be conducted on the feasibility of your research within the scope of the basic information for users provided by the secretariat. | |
| Submission of Application for P-MICS DB Usage | To request P-MICS DB usage, please submit an Application for P-MICS DB Usage (Form 1) for each unit of usage application to the secretariat. | |
| Review of Application for P-MICS DB Usage | When an application for P-MICS DB usage is submitted, the Chief Operations Officer (COO, i.e., Chairperson of the NCCHD) will review the application for P-MICS DB usage based on the criteria. In reviewing the application, the COO should, in principle, seek the opinions of the Expert Review Committee. The COO will decide whether or not to approve the application for P-MICS DB usage based on the results of the opinions of the Expert Review Committee. The secretariat will notify the applicant in written form on the results of the review regarding the approval or disapproval of P-MICS DB usage. | |
| Receiving Results of the Application Review | The secretariat will notify the applicant about the results of the Review on P-MICS DB Usage (Form 2). | |
| Conclusion of Contract for P-MICS DB Usage | Prior to the P-MICS DB usage, a usage agreement including the conditions of the usage must be signed between the COO and the applicant for the approved usage. After approval by the Collaborative Research Review Committee, the contract will be signed. Ethical review of the research must be conducted and approved by the applicant's institution before the agreement is signed. | |
| (Only if changes are made to the usage plan) | ||
| Submission of Analysis Plan | After signing the contract for use, the contractor is required to submit an analysis plan to the secretariat. The database user will execute the analysis by remote access to the P-MICS DB from a designated computer terminal in the statistical analysis area, following the analysis plan. |
|
| Submission of Application for Statistical Information Transfer | After the analysis is finished, the database user will organize the statistical information to be transferred outside the statistical analysis area. The contractor of the P-MICS DB usage should fill in the blanks of the Application for Statistical Information Transfer of P-MICS DB Usage (Form 6), and submit it to the head of the secretariat. The head of the secretariat will check the Application for Statistical Information Transfer of P-MICS DB Usage (Form 6) and the statistical information and any other information stored in the statistical analysis area, and then decide whether the statistical and other information can be transferred. If the head of the secretariat determines that the statistical information transfer is acceptable, the database user shall transfer the statistical information and the analysis report created using the statistical information from the designated computer terminal to the outside, and submit it to the secretariat. |
|
| Receiving Analysis Results | The secretariat prepares statistical information and analysis reports on storage media with security functions or read-only storage media, and notifies the contractor of the delivery of the analysis reports. At the time of delivery, the Agreement on Statistical Information Transfer for P-MICS DB Usage will be exchanged as a proof of the delivery of the recording media with security functions or read-only storage media. | |
| Submission of Application for Publication | The contractor should submit an application to the secretariat with the materials to be publicized, clearly indicating the correspondence with the approved use and the desired response period regarding approval or disapproval of the publication. The COO should seek the opinion of the Expert Review Committee on the applicability of the publication criteria to the material to be publicized. |
|
| Receiving Results of Publication Review | The COO decides whether or not to allow publication based on the opinions of the Expert Review Committee, and the secretariat communicates the decision to the Liaison Representative. | |
| Report on Publication of the Usage | The publicized material should clearly indicate that it is the result of P-MICS DB usage, and the contractor should report the summary of the achievements, including the publication media, to the secretariat promptly after the publication, using Form 11, Report on Achievements of P-MICS DB Usage. | |
| Submission of Final Report on the Usage | The Contractor must submit the Final Report on P-MICS DB Usage (Form 12) to the secretariat by the end of the contract period. |
2.Contact Information for Document Submission
Secretariat of the Pediatric Medical Information Collection System
