5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any regulatory authority (e.g., RA/EC)?

No. In accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, and for ensuring that the investigators are qualified by training and experience.

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?  

No, the documents are the same whether the PI is located inside or outside the country.

5.3 Does local authority allow electronic ICF administration including electronic signatures?  

Yes.

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded? 

This is not mandatory. However, if consent is provided verbally (over the phone), the method of gaining consent needs to be recorded.

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)? 

Electronic Data Processing System

When using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance and that he/she maintains standard operating procedures for using these systems. The sponsor should base his/her approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and the reliability of trial results. Sponsors should ensure that research facilities are prepared for inspection by the Thai Food and Drug Administration (Thai FDA) by ensuring that research participant source data and case report forms are stored in electronically-based data collection systems.

Records Management

Sponsor-specific essential documents should be retained until at least two years after the last approval of a marketing application in an ICH region until there are no pending or contemplated marketing applications, or at least two years have elapsed since the formal discontinuation of an investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

The sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

No, in Thailand, any product to be used in a clinical trial needs to be provided in a controlled manner via the sponsor.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs Interventional Study)?   

No, in Thailand, any product to be used in a clinical trial needs to be provided in a controlled manner via the sponsor.

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range? 

Reasonable expenses may be paid to trial participants to cover costs. Phase I trial participants should be compensated for travel, loss of work, or other expenses incurred while participating in the trial.

5.9  Specific labeling requirements for clinical study product 

Investigational Product (IP) labeling in Thailand must comply with the requirements set forth in the Guidance for Ethical Research (2007), the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (THA-28), and Nor Yor Mor 1 form. The IP must be coded and labeled in a manner that protects blinding, if applicable.

In general, primary and secondary labels MUST contain (at least) the following requirements:

1. All containers and packaging of all sizes are to use the same format as the actual label.
2. Thai language should be used, except for the drug name/drug code and research project sponsor information, where Thai or English language may be used; in the case of drugs administered by medical study personnel, the label information may be submitted in Thai or English.
3. Drug name/drug code, strength, pharmaceutical form, drug delivery system, unit quantity; in the case of a blind treatment study, the label must specify: “Placebo or [Drug Name/Drug Code] + [Strength]”.
4. Research project code or name.
5. Production model and/or code number to identify components and packaging process.
6. Participant number or treatment number and appointment number (if applicable).
7. Methods of drug use may refer to documentation specifically describing participants (such as drug use records) or to communicate how medical study personnel can correctly administer the drug product.
8. Name, address, and telephone of the sponsor, contract research organization (CRO), or the investigator (main point of contact for clinical research product information and emergency treatment disclosure), unless the participant receives an identification card displaying this information (with attached documents) and is advised to keep this document in his/her possession at all times.
9. Statement indicating “for clinical research purposes only” or in other words with the same meaning in the Thai language.
10. Drug storage conditions.
11. Period of use (use as appropriate within the expiration date or retest date) in months/years and in a manner that avoids ambiguity.
12. Statement indicating “keep out of the reach of children” in Thai or in other words meaning the same in Thai, unless the participant is not going to take home the medicine.

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics? 

The Thai FDA is also responsible for authorizing the import of IPs. The Thai FDA’s approval of a drug import license application for clinical trial purposes serves as the import license using the Nor Yor Mor 1 form. 

The following documents are also required to be submitted to the Thai FDA:

1. Import license application
2. Ethics committee (EC) approval letter
3. Local importer’s authorization
4. Protocol
5. Investigator’s brochure (IB)
6. Informed consent form
7. Package insert
8. Label (Thai - necessary, English - optional)
9. Quantity estimation for import (Note: the applicant is permitted to request for overages (not more than 20%) in the application)
10. Proforma invoice (applies to international exporters)

5.11 What is the turn-around time to get an import permit?

The overall approval time is typically 30 days.

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

There is no specific guidance regarding the destruction of material.