- E-learning
- The Collection, Retrieval, and Preparation of Specimens
- Procedures to Participate in the Repository
- Returning Specimens and Data
- Registering Cases
- Entering Clinical Information
- Other
E-learning
Q1. Which persons from the cooperating research institutions should take the e-learning courses?
We ask that all Repository Portal account holders take the e-learning courses. Specifically, this applies to individuals such as 1) iCROWN research cooperation managers (those responsible for institutions related to iCROWN), 2) those responsible for biological specimens, 3) those handling the management and packaging of biological specimens, 4) those handling consent confirmation and identity verification, 5) those issuing REBIND-IDs, 6) those entering clinical information into REDCap, and 7) those handling hospital information systems.
Q2. Regarding e-learning, is it possible to complete alternative courses in place of the Japan Society for the Promotion of Science research ethics e-learning?
Among others, the following courses may be used as alternatives if completed within the past five years: the ICR-web Basic Knowledge of Clinical Research Course “Chapter 9 Research Ethics and Subject Protection,” the eAPRIN Standard Course for Medical Researchers, the Recommended Course for Medical Researchers, or the Life and Medical Sciences Course. Please upload course participation/completion certificates in PDF format to the designated location in the Repository Portal. Please note that only official course certificates will be accepted.
The Collection, Retrieval, and Preparation of Specimens
Q1. How are various specimens transported after they have been collected?
Testing companies under contract with iCROWN will collect specimens on-site and transport them. Please submit all specimens to the testing company on the day of collection or the following day.
Q2. Is specimen collection available on Saturdays and Sundays?
Specimen collection is available only Monday to Friday. Collection requests and actual collection are not available on Saturdays, Sundays, and public holidays. However, if specimen collection is to be conducted on a holiday that falls before a business day, testing company collection can generally be arranged for the next business day if the testing company is notified on the morning of the next business day. For facilities already participating in the iCROWN Repository, please refer to “6.1 Collection Points and Specimens” and “7.4 Specimen Collection Requests” in the “Operations Manual - For Collaborating Institutions -.”
Q3. We forgot to request a specimen collection, and two days have passed since our collection. In such case, how should we handle the specimen?
We ask that you do not dispose of the specimen and notify a testing company regarding collection. Please note that specimen collection is generally not advised if you anticipate not being able to submit the specimen on the day of collection or the day after.
Q4. How should we handle excess or unused triple-packaging kits and specimen collection containers?
Please ensure these items are disposed of appropriately, such as at each institution.
Q5. For cases in which the date of hospitalization, diagnosis, and consent are all different, which date should be used as the reference point for specimen collection?
If Point 1 specimen collection is conducted on the date of consent, please use this date as the reference point. If you were not able to conduct Point 1 specimen collection on the date of consent, use the date of Point 1 collection as the reference point. For example, if the date of consent is designated as Day 0, and Point 1 specimens are collected on Day 1, collect Point 2 specimens on the reference point of Day 4, which is three days after Day 1.
Q6. Are the physicians registered in the Repository Portal the only ones who can collect specimens?
If the task is limited only to specimen collection, other physicians, clinical laboratory technicians, nurses, etc. can also perform the collection in addition to the registered physician. However, regarding the management and packaging of the specimen after collection, these tasks may only be performed by a Repository Portal account holder who has been approved after completing the e-learning courses to minimize the risk of infection for practitioners.
Q7. What types of cases are eligible for the collection of sputum specimens for the target condition SARI?
Sputum specimen collection is requested for cases in which the causative pathogen has not been confirmed, along with Class II Infectious Diseases (both confirmed and suspected). Regarding the selection of eligible cases, please refer to the various FAQs published in Related Documents available after logging in to the Repository Portal.
Procedures to Participate in the Repository
Q1. What procedures are necessary for medical institutions to join the iCROWN Repository?
Collaborating research institutions do not require ethics screening. However, we ask that you follow procedures for participation as a “collaborating research institution,” which include reporting/notifying your institution head and obtaining relevant permits, as you will be required to newly collect specimens and data for submission to the Japan Institute for Health Security as an institution cooperating with research.
The reports to be submitted shall be prepared in a format in accordance with those published in the “Ethical Guidelines for Medical and Biological Research Involving Human Subjects,” and these will be made available in the Repository Portal after login. Please use the templates if your institution does not have a designated format. If your institution does have a designated format, please use it to create the reports.
Q2. At what stage are administrative procedures for contracts, etc. carried out?
Institution registration will be done at the Repository Portal, so we ask that you register the necessary information and materials after logging in to apply. Contract procedures will follow after the content has been reviewed by the iCROWN Administrative Office. However, if the contract template is still being prepared by the Ministry of Health, Labour and Welfare and the Japan Institute for Health Security, contract procedures may not begin right away.
Q3. May we register cases as soon as all materials are ready?
Please log in to the Repository Portal and download the Operations Manual in “Related Documents.” You may begin case registration once all items published in “2. Preparation for Participation as a Collaborating Research Institution” of the Operations Manual have been completed.
The Material Transfer Agreement (MTA) for Specimens and Related Materials will be finalized and go into effect on the date that research cooperation at your institution is approved.
Returning Specimens and Data
Q1. Will the specimens and data collected by the iCROWN Repository be returned to the institutions?
We will return specimens and data (clinical information, pathogen genome information, human genome information, some portions of processed specimens) collected from institutions upon request from collaborating research institutions that have registered cases. The return frequency is currently under deliberation. However, clinical information will be provided once every two months, and other items approximately once a year. For this reason, it is expected that prompt return will be difficult.
Q2. What is the type and amount of specimens if we wish to be returned for the specimens collected at our institutions and provided to the iCROWN Repository?
In principle, if you have provided a sufficient amount of specimens, DNA, plasma, and PBMC per 1 collection point will be returned.
Q3. Regarding specimens returned to collaborating research institutions, is it possible to provide these specimens to other research institutions for collaborative studies and use them for research?
Specimens may be utilized for collaborative research with other research institutions within the scope of consent obtained under the research plan of the iCROWN Repository. Please use these specimens for purposes approved by the ethics review committee at each institution. Please note that when publishing papers and other materials, we ask that you include a disclosure in your methods/acknowledgements such as “specimens were provided by iCROWN.”
Registering Cases
Q1. If consent is obtained, is it possible to register cases of patients who have been confirmed to be long-term positive with regard to testing for targeted infectious diseases?
It is possible to register such cases if the inclusion/exclusion criteria listed in the case report form (CRF) for each disease are fulfilled.
Q2. How should collaborating research institutions prepare documents for informed consent?
Please log in to the Repository Portal and download and print out from the “Related Documents.” Please note that you will be required to enter the name of the collaborating research institution in some areas, so use these documents after entering the institution name. We ask that you download the Operations Manual and refer to “2.8 Preparation of Informed Consent Materials.”
Q3. Is it possible to obtain consent from a legal representative?
Yes. For details, please log in and download the Operations Manual and refer to “Patient Registration/Informed Consent (IC) Acquisition.”
Q4. We reobtained consent for a case already registered in the iCROWN Repository. How should this be entered in the Repository Portal?
We ask that one kit ID be used for one infectious disease and entered only once when entering kit IDs, consent dates, and consent form versions in the Repository Portal. After reobtaining consent, if you are using a different kit ID from the one previously registered, please enter the new kit ID, the consent date of the newly obtained consent, and the consent form version into the Repository Portal, and reregister the case under the same medical record ID as the previous one. However, please note that for cases in which consent is reobtained twice or more for the same infectious disease and a new kit ID is not being used, do not register this information in the Repository Portal and contact the iCROWN Administrative Office instead.
Entering Clinical Information
Q1. Regarding the electronic data capture (EDC) report, when are queries issued and when are data locks conducted for each case?
Queries are issued for each case once the required forms for the case have been tagged as “Complete.” Furthermore, once all necessary forms have been completed for each case, the status has been tagged as “Complete,” and all suspects regarding data have been resolved, the data of the cases will be locked.
Q2. What electronic data capture (EDC) product does iCROWN use?
We use REDCap.
Q3. How do we acquire an electronic data capture (EDC) account?
In order to acquire an EDC account, a user account for the Repository Portal is required. If your medical institution is registered as an institution that conducts case registration, there should be a Repository Portal account administrator at your institution. Please have them issue a user account. When doing so, please select “Use EDC.” After your account has been issued, you will be required to take e-learning courses before approval. EDC accounts shall be issued on the Monday following the approval date.
Q4. How do we delete a case if we mistakenly register one in the electronic data capture (EDC) report?
You are not able to delete cases with your institution’s REDCap account. To request the deletion of a case, please contact the iCROWN Administrative Office and provide the case PIN number and the REBIND-ID for deletion, and the reasons and background for the deletion request.
Other
Q1. How will the GISAID registration information entered in the institution information of the Repository Portal be used?
When virus genome information is registered in GISAID, it is utilized as the information of the institution where the specimen was collected.
When virus genome analysis is conducted, the data along with the prefecture in which it was detected, are registered at the National Institute of Infectious Diseases into public databases such as the international genome database GISAID (Global Initiative on Sharing All Influenza Data), to be made available worldwide. During this process, the name of the medical institution at which the original virus specimen was collected is also registered.
Entering the name of your medical institution and the staff responsible for specimen collection will enable results to be attributed to your institution, which we believe is meaningful. If you wish not to disclose your medical institution’s name, that field may be left blank. In such cases, the specimen collection location will be registered as the National Institute of Infectious Diseases.
Q2. Will the iCROWN Administrative Office make presentations at conferences or publish papers using specimens and data from the iCROWN Repository?
There is a possibility that the aggregated results of the collected specimens and data will be summarized and presented at conferences or published in papers. Furthermore, there is the possibility of the iCROWN Administrative Office applying as a user, and after being reviewed and approved, using the specimens and data for research that may be presented at conferences or published in papers.