Guidelines

JCROA Guideline

Foreword

The following points are the most important to be understood and followed with regard to clinical trials conducted in Japan. The regulatory authority in Japan has expressed significant concerns regarding the following items, which must be performed without fail.

• 1. In any clinical trial in Japan, safety information is reported to the regulatory authority no later than 7 calendar days, in the earliest case, after first knowledge of incidence. Reporting obligations arise at the time of submitting a notification of a clinical trial plan.
• 2. For safety information, the date the information is obtained by a foreign sponsor or by the ICCC, whichever is earlier, is regarded as the date for obtaining initial information.
• 3. A foreign sponsor and the ICCC must always include items on reporting safety information in any contract between them after understanding the description above. If there is an affiliate company in Japan, the extent of its involvement must be confirmed.

In association with the guidance documents “Essential Considerations on Requesting a Clinical Trial In-Country Representative <For Foreign Sponsors> issued by Japan CRO Association, June 2017

* Clinical Trial In-Country Representative is referred to as In-country Clinical Care-taker (ICCC) in this document

The Guideline stipulates the basic principles to continue the business activities by ensuring the reliabilities and quality of contracting services.

The Guidelines aim at increasing the clients’(prospective sponsor) reliabilities and developing by observing the Guideline by each Association Member and its further expansion and growth in the entire industry.