April 17, 2020
Japan Association of Site Management Organizations
Japan CRO Association
Clinical Evaluation Expert Committee,
Drug Evaluation Committee in Japan Pharmaceutical Manufacturers Association
All the member companies
Hideki Tsukahara, the chairperson of Japan Association of Site Management Organizations
Hisashi Uematsu, the chairperson of Japan CRO Association
Mitsuhiro Kondo, the chairperson of Clinical Evaluation Expert Committee,
Drug Evaluation Committee in Japan Pharmaceutical Manufacturers Association

Implementation and Management, etc. of Clinical trials
under the spread of the novel coronavirus (COVID-19)

Dear All
We believe that you are in healthy and have prosperity.
We would like to deeply thank you for your support for activities of Japan Association of Site Management
Organizations, Japan CRO Association and Clinical Evaluation Expert Committee, Drug Evaluation
Committee in Japan Pharmaceutical Manufacturers Association.
In these days, the novel coronavirus has been widely spreading, and the government declared a nationwide
state of emergency.
We have been informed that deviations from protocols and standard operating procedures, etc. have been
occurring or occurrences of such deviations have been concerned to carry out clinical trials under such an
unprecedented situation. On the other hand, we have to assign top priority to the trial subjects’ safety andconsider ways to ensure quality of clinical trials. Ministry of Health, Labour and Welfare and Pharmaceuticals
and Medical Devices Agency have issued related notifications.
Also, in such a tensed situation, we have received the following reports as voices of clinical trial sites throughpersonnel of the member companies of Japan Association of Site Management Organizations who are having
direct contact with subjects on the front lines of clinical trials:
 Examinations, observations and evaluations can not be conducted within the allowable visit window as
it became difficult for subjects to visit trial sites.
 While there are many consultations from subjects regarding adjustment of their visit schedules toprevent infection, there are cases that sponsors (including CROs) strongly request to adjust visit
schedules with subjects within the allowable visit window.
 In response to requests from medical institutions to refrain from non-urgent visits to CRAs as well as
CRCs, their supportive operations at sites have been interfered.
 Requests for excessive remote SDV may cause not only an increase in work burden under the intense
situation but also an increase in human contacts. Eventually it may cause the spread of the coronavirusand the collapse of the medical care system.
CRCs have been feeling exhausted, while making a huge effort to prevent the infection spread and thecollapse of the medical care system, by being requested to enroll the scheduled number of subjects inclinical trials under the situation in which medical institutions are facing difficulties in maintaining
medical examination systems.
Under the suspicious situation that CRCs engaged in clinical trials may be infected or close contactpeople, a conflict between keeping the staffs available and ensuring their safety has been happening.

Various decisions are required for carrying out clinical trials under such circumstances. However, we believethat it is significant to ensure ethicality, science and reliability which are the principles of GCP and then makedecisions.
Given the above background, in order to corporate for measures to prevent the infection spread, Japan
Association of Site Management Organizations, Japan CRO Association and Clinical Evaluation Expert
Committee, Drug Evaluation Committee in Japan Pharmaceutical Manufacturers Association strongly
recommend the followings:
 First and foremost, ensuring safety of subjects and medical service workers should be considered as a
top priority to prevent the collapse of the medical care system. Therefore, please note that non-essential
work requests should be refrained between concerned parties.
 If deviations from protocols and standard operating procedures, etc. are assumed, please discuss
measures for the deviations in advance with those concerned. As a measure, revision of the protocols
and/ or standard operating procedures may be considered. Also, sponsors should consider consultingwith Pharmaceuticals and Medical Devices Agency if necessary.
 Deviations should never be overlooked, disregarded and suppressed by the confusion due to the impactof the novel coronavirus. Please instruct personnel engaged in clinical trials from a viewpoint of data
integrity so that they can immediately report to you, contact you and consult with you.
When deviations occur, please report the deviations to those concerned in consideration of priority levels
such as urgency and importance, etc., discuss measures and keep records about the background andmeasures.
 There are many cases that CRCs, CRAs and auditors, etc. need to visit medical institutions even undersuch circumstances. It may be possible to reduce the number of visits by discussing necessary measureswith investigators, etc. at medical institutions such as performing only the minimum amount of workrequired to carry out clinical trials properly and reducing the number of paper-based materials as far as
possible. Also, please consider promoting ICT infrastructure which enables you to work remotely ateach company and medical institution.
We have been facing difficulties. However, we believe that it is necessary for SMOs, CROs andpharmaceutical companies to cooperate closely and take appropriate measures by sharing the belief of"Respect each other" to overcome such difficulties. We understand that all of you are having various
difficulties in daily life while the situation is changing day by day. Lastly, again, we would like to ask you tounderstand the above-mentioned actions to be done and calmly deal with all cases so that the data fromsubjects who are enrolled in the clinical trials voluntarily may not be wasted.
End.