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Evaluation Instrument for Accreditation

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Latest Update: February 16, 2026
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Table of Contents

INTRODUCTION
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATION
THE FIVE SECTIONS OF ELEMENTS AND STANDARDS
LIST OF STANDARDS AND ELEMENTS
GLOSSARY OF TERMS
SUMMARY OF REVISIONS
DOMAIN I: ORGANIZATION
STANDARD I-1  
ELEMENT I.1.A. ELEMENT I.1.B. ELEMENT I.1.C. ELEMENT I.1.D. ELEMENT I.1.E. ELEMENT I.1.F. ELEMENT I.1.G. ELEMENT I.1.H.
STANDARD I-2
STANDARD I-3
STANDARD I-4  
ELEMENT I.4.A. ELEMENT I.4.B. ELEMENT I.4.C.
STANDARD I-5  
ELEMENT I.5.A. ELEMENT I.5.B. ELEMENT I.5.C. ELEMENT I.5.D.
STANDARD I-6  
ELEMENT I.6.A. ELEMENT I.6.B.
STANDARD I-7  
ELEMENT I.7.A. ELEMENT I.7.B. ELEMENT I.7.C.
STANDARD I-8  
ELEMENT I.8.A. ELEMENT I.8.B. ELEMENT I.8.C. ELEMENT I.8.D. ELEMENT I.8.E.
STANDARD I-9
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
STANDARD II-1  
ELEMENT II.1.A. ELEMENT II.1.B. ELEMENT II.1.C. ELEMENT II.1.D. ELEMENT II.1.E.
STANDARD II-2  
ELEMENT II.2.A. ELEMENT II.2.B. ELEMENT II.2.C. Element II.2.D. Element II.2.E. Element II.2.F. Element II.2.G. Element II.2.H. Element II.2.I.
STANDARD II-3  
ELEMENT II.3.A. ELEMENT II.3.B. ELEMENT II.3.C. ELEMENT II.3.D. ELEMENT II.3.E. ELEMENT II.3.F. ELEMENT II.3.G.
STANDARD II-4  
ELEMENT II.4.A. ELEMENT II.4.B. ELEMENT II.4.C.
STANDARD II-5  
ELEMENT II.5.A. ELEMENT II.5.B.
DOMAIN III: RESEARCHER AND RESEARCH STAFF
STANDARD III-1  
ELEMENT III.1.A. ELEMENT III.1.B. ELEMENT III.1.C. ELEMENT III.1.D. ELEMENT III.1.E. ELEMENT III.1.F. ELEMENT III.1.G.
STANDARD III-2  
ELEMENT III.2.A. ELEMENT III.2.B. ELEMENT III.2.C. ELEMENT III.2.D.
TABLES
TABLE II.2.A.1.
TABLE II.2.C.1.
TABLE II.2.F.1.
TABLE II.3.F.1.
TABLE II.3.G.1
TABLE II.3.G.2.
INTERNATIONAL ADDENDA
Country-Specific Addenda

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

  1. Essential requirements:
    1. Policies and procedures describe the control of investigational drugs.
    2. Policies and procedures describe the control of investigational devices.
  2. When following ICH-GCP(E6)(R2) guideline:
    1. Investigators should maintain records that document adequately that the participants were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
  3. When following ICH-GCP(E6)(R3) guideline:
    1. 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).
    2. The investigational product may be administered at the participant’s location by investigator site staff, the participant themselves, a caregiver or a healthcare professional.
  4. When following ICH-GCP(E6)(R2) or ICH(E6)(R3) guidelines:
    1. Responsibility for investigational product(s) management, including accountability, handling, dispensing, administration and return, rests with the investigator/institution.
    2. 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.
    3. The researcher, pharmacist, or other designated individual maintains records of the product's delivery to the clinical trial site, the inventory at the site, the use by each participant, and the return to the sponsor or alternative disposition of unused products. These records include dates, quantities, batch or serial numbers, and expiration dates (if applicable), and the unique code numbers assigned to the investigational products and trial participants.
    4. The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).
    5. Where applicable, the investigator or a person designated by the investigator/institution should explain the correct use of the investigational product(s).

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.

Proceed To: ELEMENT I.7.C.