ELEMENT I.7.B.
ELEMENT I.7.B.: The organization has and follows written policies and procedures to ensure that the handling of investigational or unlicensed test articles conforms to legal and regulatory requirements.
This Element applies only to an organization that conducts research with test articles or investigational products or an independent IRB or EC that reviews a researcher’s plan to control test articles or investigational products.
An organization should describe the process for handling test articles or investigational products so that they are used only in approved protocols and under the direction of approved researchers. Possible methods organizations can use to control investigational drugs and devices are:
- Protocol-by-protocol review and approval of the researcher’s plan to control test articles or investigational products along with training or evaluation of researchers on knowledge and compliance with the plan.
- Organizational control of test articles or investigational products. For example, organizations can control investigational drugs by having a pharmacy store them and dispense them only under the prescription of an approved researcher.
Procedures for the control of investigational drugs and devices should apply to all settings in which the organization uses investigational drugs and devices, such as inpatient, outpatient, on-site, and off-site settings.
Regulatory and guidance references
Required written materials
- Essential requirements:
- Policies and procedures describe the control of investigational drugs.
- Policies and procedures describe the control of investigational devices.
- When following the ICH-GCP(E6)(R3) guideline:
- Policies and procedures include:
- Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be managed in accordance with the product specifications and the trial protocol.
- Responsibility for investigational product(s) management, including accountability, handling, dispensing, administration and return, rests with the investigator/institution.
- When the investigator/institution delegates some or all of their activities for investigational product(s) management to a pharmacist or another individual in accordance with local regulatory requirements, the delegated individual should be under the oversight of the investigator/institution.
- The investigator/institution and/or a pharmacist or other appropriate individual should maintain records of the product’s delivery, the inventory, the use by each participant (including documenting that the participants were provided the doses specified by the protocol) and the return to the sponsor and destruction or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable) and the unique code numbers assigned to the investigational product(s) and trial participants. For authorized medicinal products, alternative approaches to the aforementioned may be considered, in accordance with local regulatory requirements.
- The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).
- The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol.
- Where applicable, the investigator or a person designated by the investigator/institution should explain the correct use of the investigational product(s).
- The investigational product may be shipped to the participant’s location or supplied to/dispensed at a location closer to the participant (e.g., at a local pharmacy or a local healthcare center).
- The investigational product may be administered at the participant’s location by investigator site staff, the participant themselves, a caregiver or a healthcare professional.
Outcomes
- Test articles or investigational products are used only in approved research protocols and under the direction of approved researchers.
- The organization has a process to ensure the proper handling of test articles or investigational products.