Chương VI Thông tư 29/2018/TT-BYT: Đoàn đánh giá việc đáp ứng thực hành tốt thử thuốc trên lâm sàng

Chapter VI

INSPECTORATE CARRYING OUT INSPECTIONS OF MAINTENANCE OF GCP COMPLIANCE

Article 16. Members and standards to be satisfied by members of an inspectorate

1. The Minister of Health shall decide to establish an inspectorate, which includes:

a) the chief: a senior representative of the receiving authority;

b) 01 secretary: a specialist of the receiving authority;

c) Representatives of affiliates of the Ministry of Health (each affiliate appoints a representative only), including Medical Services Administration; Department of Legal Affairs; National Biomedical Ethics Committee; Drug Administration of Vietnam; the Administration of Science Technology and Training; Agency of Administration of Traditional Medicine if the provider of trial services conducts clinical trials of herbal drugs and traditional drugs;

d) 01 representative: a representative of the Department of Health of provinces and central-affiliated cities (hereinafter referred to as “the Department of Health”) where the trial facility’s headquarters is located if the trial facility is affiliated to the Department of Health;

dd) Members of relevant authorities and units where necessary.

2. A member of the inspectorate must satisfy the following standards:

a) He/she must obtain at least a bachelor’s degree;

b) He/she has attended training courses in GCP standards and inspection of GCP compliance;

c) He/she must be honest, objective strictly comply with regulations during the inspection and must not create any conflict of interest with the inspected provider as prescribed in Clause 3 of this Article;

d) The chief must obtain at least a bachelor’s degree in medicine or pharmacy and have at least 05 years’ experience in clinical trial management.

3. Rules for assessing the conflict of interest: A member of the inspectorate shall be deemed to involve a conflict of interest with the inspected trial facility in one of the following cases:

a) He/she has worked for the inspected provider in the past 05 years;

b) He/she has provided consulting services for the inspected trial facility in the past 05 years;

c) He/she is receiving financial benefits associated with the inspected trial facility;

d) his/her spouse, child, parent, sibling or parent-in-law is working at the inspected trial facility.

Article 17. Rights and responsibilities of an inspectorate

1. The inspectorate has the responsibility to:

a) inspect all operations of a trial facility according to corresponding GCP prescribed in Article 4 of this Circular, updated GCP documents (if any) and relevant applicable regulations; clearly record inspection contents and deficiencies found, prepare GCP inspection records and reports;

b) prepare or provide explanation for the GCP inspection compliance report if the trial facility has any disagreements with the report;

c) maintain confidentiality of information about the inspection and about clinical trials by the trial facility, unless otherwise agreed by the trial facility or at the request of a competent authority.

2. The inspectorate has the right to:

a) inspect all areas in service of clinical trials;

b) request the trial facility to provide documents concerning its operation;

c) collect documentary evidences (by copying documents, taking pictures or recording videos) of any deficiencies found during the inspection;

d) make inspection records and request the trial facility to suspend its operation if the inspectorate detects any violations which may cause adverse effects on safety and health of trial subjects or accuracy and truthfulness of trial data and request the competent official to impose penalties against such violations as prescribed.