Clinical Trial Accidents, Adverse Events, and Case Report Form Reliability
First written in FY2016. 3 of 4 entries say "Restated". Latest entry: FY2020.
1 other company's latest entry also says "Restated".
- FY2020RestatedAnnual report
「If a CRA of the Group fails, due to negligence or other reasons, to comply with standard operating procedures for clinical trials or other regulations in a clinical trial involving the Group, resulting in problems with the reliability or other aspects of the collected case report forms, and the Group is liable for damages caused to the pharmaceutical company commissioning the trial, or loses the confidence of pharmaceutical companies other than the commissioning company, the Group's performance could be affected by litigation or a decline in the number of clinical trials contracted.」
The risks of a loss of confidence, litigation and a decline in contracted trials arising from clinical trial incidents, adverse reactions, regulatory violations and reliability problems with case report forms continue. - FY2018RestatedAnnual report
「The Group provides CRAs with continuous training as part of its day-to-day operations and works to ensure quality. Pharmaceutical companies bear direct responsibility when adverse reactions to investigational drugs occur. However, if the CRO industry as a whole, including the Group, loses the confidence of pharmaceutical companies because of a serious adverse reaction or other major incident in a clinical trial in which it is involved, or if the Group is unable to respond adequately, including by reporting to the customer, when such an incident occurs in a clinical trial involving the Group, the Group's performance could be affected by a decline in the number of clinical trials contracted or by litigation.」
The disclosure describes continuous training for CRAs while continuing to disclose the risks of a loss of confidence, litigation and a decline in contracted trials arising from serious adverse reactions, major incidents, inadequate reporting and reliability problems with case report forms. - FY2017RestatedAnnual report
「If the CRO industry as a whole loses the confidence of pharmaceutical companies because of a serious adverse reaction or other major incident in a clinical trial involving the Group, or if the Group is unable to respond adequately, including by reporting to the customer, when such an incident occurs in a clinical trial involving the Group, the Group's performance could be affected by a decline in the number of clinical trials contracted or by litigation.」
The risks of a decline in contracted trials or litigation arising from serious adverse reactions, major incidents, inadequate customer reporting and reliability problems with case report forms continue to be disclosed. - FY2016First statedAnnual report
「If a serious adverse reaction or other major incident occurs in a clinical trial involving the Group and the Group is unable to respond adequately, including by reporting to the customer, the Group's performance could be affected by a decline in the number of clinical trials contracted or by litigation.」
Problems with data reliability caused by major incidents, adverse reactions or regulatory violations could lead to a loss of confidence, litigation and a decline in contracted trials.