In the process of project establishment, attention should be paid to:
1.SMO:① Are there any specific requirements for the templates we can use? Are there any specific requirements for the template hospital of SMO contract? Is there a time limit for contract review? Will the use of hospital templates increase the audit process? (2) Does the hospital have fixed cooperation units and related personnel for SMO and China Resources participating in the project, so as to prevent the applicant from failing to meet the needs of the center or department?
2. Agreement: ① The template of the agreement requires that the hospital template will speed up the audit process. ② Node of agreement review: review after project establishment? With ethical review? Has everything to do with heredity? How many copies do you need to sign? CRO/ Does the applicant or the hospital sign first?
3. Material preparation: ① Do you accept the mailing of relevant project materials? (2) How many project documents are needed? What materials need PI to sign in advance? Is there any relevant hospital template to collect PI resume?
4. Process: ① Is cra allowed to check HIS, specific operation and reservation process? (2) Does the project need a formal review/meeting, and does it need a fee?
Matters needing attention in this stage of ethical review, first of all, we should pay attention to the ethical cycle and the deadline for submitting materials; Secondly, it is necessary to clarify the specific number of copies and stamp requirements of the submitted materials, and know in advance whether other special seals are needed; For related ethical expenses, it is necessary to obtain the hospital account number, understand the requirements of payment bills, send relevant vouchers and issue invoices.
?
This stage mainly involves defining the specific provisions of relevant special expenses. ① Are the blood collection tubes and needles used in the project included in the inspection items? Still need to be listed separately and settled separately? (2) Quality control, data storage, institutional management, etc. , does it involve costs, and are the specific requirements clear? (3) Are the fees for services such as registration reflected in the contract? Need to communicate with PI or soapy.
At the start-up stage of the center, the first work that inspectors need to prepare includes collecting relevant certificates (inter-laboratory evaluation, center qualification certificate, practicing certificate, GCP certificate), resumes (PI, resumes of researchers and nurses), and the normal scope of laboratory inspection. Prepare blank sign-in form, training record form and authorization form. (2) Secondly, it is necessary to specify the specific requirements of the storage location and arrival time node of drugs. For those who need to put medicine in the department, it is necessary to check whether the department meets the temperature requirements stipulated in the scheme, whether it is qualified, whether there is a thermometer and whether it can be exported regularly. ③ What are the specific requirements and time nodes for the quality control of the center? ④ In addition, it is necessary to obtain templates, SAE reports, annual review reports and plan deviation reports that may be needed by relevant hospitals.
? In the group follow-up stage, pay attention to the deadline of relevant documents, understand the requirements of relevant documents, update relevant certificates, approvals or submit relevant reports in time.
? At this stage, we should pay attention to the relevant processes, material filing requirements, and clarify the cost settlement requirements.