Why the affidavit is needed? – CURE51 Help Center

Category: Legal and Regulatory

Labels: affidavit

Creation date and Author: Merry K., August 8th 2025

Last Update and Author: Merry K., August 8th 2025

Related questions: NA

The affidavit is a needed to guarantee:

Patient Protection and Informed Consent: The "affidavit" or statement often serves as a formal declaration from the investigator that the samples were collected ethically, with proper informed consent, and in accordance with the study protocol and applicable regulations.
Sample Integrity: To ensure the scientific validity of the trial results, the integrity of the samples must be maintained throughout their journey. The "affidavit" can confirm that samples were collected, processed, and stored according to the protocol and relevant standards (e.g., Good Clinical Laboratory Practice - GCLP), and that a proper chain of custody has been maintained.
Regulatory Compliance: Importing biological materials, especially human samples, is subject to strict regulations in both the exporting and importing countries. The investigator's affidavit helps assure regulatory authorities that the samples are legitimate, properly sourced, and handled in compliance with local and international laws.
Proof of Legitimate Research Activity: Regulatory bodies and customs officials need assurance that the imported samples are for legitimate research purposes and not for unauthorized commercial or other activities. The investigator's statement provides this necessary context.

This supports the Good Clinical Practice (GCP) Guidelines (ICH E6(R2)) Good Clinical Practice: It requires sponsors and investigators to ensure that all trial-related activities, including sample handling and transfer, are conducted in accordance with the protocol, ethical principles, and applicable regulatory requirements. An investigator's statement serves as evidence of this adherence. Key principles within ICH GCP related to data integrity, subject protection, and proper documentation indirectly lead to the need for such statements.