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Introduction to the implementation of drug clinical trials

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Drug clinical trial project establishment - implementation - closing general process instructions 

1. Our institution project establishment adopts GCP platform electronic management, new users please visit the extranet site to apply for an account, and the account can be activated after approval by the institution.

2. Project pre-screening: log on GCP management platform to submit project information for project pre-screening; the pre-screening will be completed in three steps by institutional secretary - project PI - institutional secretary confirmation (no serious problems within 5 working days).

3. Project establishment: Log on to GCP management platform to submit project information again for project review; the establishment review will be completed in two steps by Institutional Secretary - Institutional Office Director (within 5 working days without serious problems).

4. Ethics approval: (Ethics office phone: 0571-81595231) Ethics meeting is held once a month in the middle and end of the month.

5. Contract review (main contract and CRC contract, see Annex 1-3 for contract templates): Institutional Office review, in-hospital countersigning (within 10 working days, contract review and ethics approval can be done at the same time.)

6. Genetic Office commitment letter signing (within 5 working days, after ethical approval is obtained, commitment letter and application letter are submitted to the institution)

7. Contract signing (within 5 working days)

8. CRA login to GCP management platform to submit scanned copy of contract

9. Appointment of project initiation meeting: After the sponsor, professional section and institution office determine the readiness of the project before initiation, agree on the time of initiation meeting and notify the institution personnel to attend.

9. In clinical trial project implementation. 

 ① After the CRA/CRC qualification is recognized by the institution, a record is made at the institution (CV, GCP certificate, commission letter, copy of ID card), work badges are issued, and visits must be signed in at the institution.

 ② Use the intranet GCP platform management system website to issue free inspection checks during the test, and contact the institution to complete the project configuration before the project starts, see Annex 4-5 for the billing process. 

③ After project initiation, go to the institution of Lingyin Hospital to complete the project online filing with the provincial bureau .

④ Make an appointment with the institution to complete the first case of QC after the first subject is enrolled.

⑤ Occurrence of program violation, drug replacement including drug test report update, SAE these 3 cases are reported to the institution promptly and quickly Annexes 6-7 (can be submitted using the project team template), SAE needs to be reported to the provincial bureau at the institution of Lingyin hospital area; SUSAR can be notified to the institution by email first, SUSAR institution receiving signature can be reported monthly or quarterly.

(vi) Supervision and audit issues are communicated with the institution in a timely manner, and reports are submitted to the institutional office in a timely manner. 

(vii) Combined medication, test and inspection traceability to the agency application after the application of the agency account for query.

⑧ Replacement of CRA/CRC must be approved by the institution and filed.

⑨ Project carried out to the middle, about the institution to carry out mid-term quality control.

⑩ Sanduan hospital area to carry out the project information please submit to Sanduan office, Lingyin hospital area to carry out the project information to Lingyin office, the institution does not accept cross-submission of information.

10. Closure of the center/project: apply for closing the center, organize the information, submit the self-examination report, cost accounting, institutional quality control, complete the collection of institutional project information, submit the sub-center summary report and summary report, and submit the information to the institutional archives for preservation. See Annex 8 for the closing process.

Note: The above work completion time, in case of special circumstances corresponding delay.

Annex 1. Zhejiang Hospital drug clinical trial contract template 2022 version Two parties

Annex 2. Zhejiang Hospital Drug Clinical Trial Contract Template 2022 Edition-Three Parties

Annex 3. Zhejiang Hospital CRC tripartite agreement Template

Annex 4-5. Free test check billing process

Annex 6-7. Submission letter template and SAE report form

Annex 8. drug project closing information

Drug clinical trial contact person and contact information (WeChat with the same number, do not disturb after working hours)

Secretary and quality control: Li He Tel: 13989816770

Drug administrator: Lin Baiyang Tel: 18267786123

Data Manager: Yao Hang Yan Tel: 13454173263

Lingyin hospital area.

Tel: 0571-87986519, 0571-81595227

E-mail: zjyyjgb@163.com

Office Address: Room 121, Outpatient Building, Zhejiang Hospital, No. 12 Lingyin Road, Hangzhou

Sandun Campus.

Tel: 0571-87377026

E-mail: zjyyjgb@163.com

Office Address: Room 306, Science and Education Building, Zhejiang Hospital, No. 1229 Gudun Road, Hangzhou