Table 5 Consideration of streamlining in clinical trials for provision of OOS products
Timing | MAHs (sponsor) | Medical institutions | |
|---|---|---|---|
Clinical Trials Before starting | Extrusion | Items that can be streamlined Preparation of Investigational Brochures (IB) may be substituted with the package inserts Items that cannot be streamlined Preparation of clinical trial protocols and informed consent forms Compensation for participants Preparation for clinical trial product management Site setup (medical institution and investigator selection, site training) Clinical Trial Notification (CTN) Clinical trial contract IRB review application preparation Maintenance of records | Items that can be streamlined Agreement with IB may be substituted with the package inserts Items that cannot be streamlined Agreement to the clinical trial protocol and informed consent form Site setup Clinical trial contract handling IRB review support |
Clinical Trials After starting | Permanent | Items that can be streamlined Storage of essential documents (case report forms, data obtained in clinical trials, and simplification of storage periods) Items that cannot be streamlined Regular confirmation of clinical trial system maintenance Evaluation of safety information, reporting to authorities and medical institutions (annual reporting, sharing of information with other sites) IRB review for protocol revisions, etc Maintenance of CTN monitoring investigators, site staff, and site trial system | Items that can be streamlined Maintenance of records (simplification of source documents and retention period) Items that cannot be streamlined Maintaining and continuing training of investigators and staff to conduct clinical trials in compliance with protocols and GCP IRB support (ongoing review, protocol revision support, etc.) |
Each time | Items that can be streamlined Procedures for converting commercial products to investigational products (product re-labelling) Collection of case report forms Handling of subject safety information EDC Verification of source data Items that cannot be streamlined Collection of case report forms Monitoring Participant eligibility Confirmation of patient consent status Ensuring the safety of participants | Items that can be streamlined None Items that cannot be streamlined Safety information evaluation, reporting to sponsor | |