Ⅰ、 Follow up
Today we are going to discuss the subjects who are in the follow-up period and need on-site follow-up. The followings are some of our implementation suggestions, which should be implemented after communicating with the sponsor and the clinical trial management department.
1. Keep in close contact with the subjects through online channels (such as telephone, wechat and other instant messaging), and the frequency can be higher than the frequency required by the clinical trial protocol itself, understand the health status of the subjects, and remind the subjects of the protective measures against novel coronavirus.
2. Confirm whether the subject has a history of residence or travel in the area with high epidemic incidence, whether there is a history of contact with people with confirmed or suspected infection, or a history of fever outpatient treatment, and remind the subject to isolate or see a doctor in time if necessary.
3. If necessary, appropriate remote follow-up procedures can be developed. The researchers contact the subjects through telephone, wechat and other instant messaging methods to understand the relevant conditions of the subjects, complete the feasible remote follow-up part of the follow-up project: such as health status, AE, concomitant medication, test drug compliance, etc., give corresponding diagnosis and treatment guidance, and guide medication. Remind the subjects to actively keep in touch with the researchers and actively feed back their personal health status and diagnosis and treatment information.
4. If it is determined that relevant inspection is needed, the principle of proximity shall be adopted, and routine inspection is recommended to be carried out in local community health institutions. When special examination is required, subjects in the urban area where the research center is located can go to the Research Center for relevant examination; Under the principle of proximity, the priority of subjects who are not in the urban area where the research center is located is: other hospitals participating in the same clinical trial (avoiding designated hospitals for medical treatment) and other hospitals with GCP qualification. If the above can not be met, go to other hospitals that can meet the examination needs.
5. The clinical trial protocol requires central laboratory inspection items. If there are difficulties in implementation, local laboratory inspection can be adopted.
6. Special inspection items that cannot be completed at present can be treated as out of visit window or missing data. Supplementary inspection shall be carried out as soon as possible when conditions permit or after the epidemic; Record and explain the corresponding protocol deviation (PD) for verification.
7. For the follow-up from the key epidemic area or the designated hospital for medical treatment to other centers, when conditions permit, the researchers of the original research center communicate with the researchers of the actual follow-up center to introduce the subject's condition, treatment process and necessary suggestions in detail.
8. Any visit to the hospital shall be registered and recorded for subsequent tracing.
Ⅱ、 Follow up
1. In view of the needs of epidemic control, it is likely to produce more PD and we should make sufficient records and explanations; At the same time, relevant data and information should be obtained as soon as possible to reduce case shedding.
2. If the visit cannot be completed due to the actual situation, it shall be communicated with the sponsor and the clinical trial management department in time. It can not be regarded as an abscission case temporarily, and it shall be treated according to the lack of visit. For cases with missing data, the use of this part of data will be discussed in the data review stage (blind review) in combination with the opinions of statistical experts and clinical experts.
(Reference - clinical trial project management measures during the epidemic period of novel coronavirus - West China Second Hospital of Sichuan University)
The above is about the follow-up during the epidemic
The next issue we will meet is about ↓
Safety information during epidemic
Please wait and see~
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As a CRO company providing clinical trial services. LINKS CRO focus on innovation, high-risk implantation(intervention) medical device, with one-stop clinical trial solutions for the whole process of medical device research and development.The headquarters of LINKS is based in Shanghai, with subsidiary branches in Beijing, Shanghai, Guangzhou, and Shenzhen, in addition to ten regional offices. The current workforce comprises almost 200 employees, with technical personnel making up over 85% and dispersed across almost 30 cities nationwide.
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