Clinical Research and Health Data Lawyers in China

Clinical research compliance is not limited to an ethics approval or a signed consent form. The operating file should connect the protocol and product-development pathway with sponsor, investigator, institution, contract research and laboratory roles; trial registration and regulatory authorization; site qualification; subject recruitment, safety and compensation; source records and data integrity; investigational product or device accountability; biological samples and human genetic resources; personal and sensitive information; vendors, systems and remote access; overseas collaborators and transfers; monitoring, audit, inspection, publication and close-out. Drug, device, investigator-initiated and observational studies can follow different rules, so the study type and intended regulatory use must be fixed early.

Questions that change the route

What study is being conducted and under whose authority?

Define product and development stage, drug, device, IVD, investigator-initiated or observational design, protocol and endpoints, sponsor and legal representative, sites and investigators, ethics review, clinical-trial authorization or notification, registration, contracts, insurance, funding and intended use of the results.

How are participants, samples, and safety protected?

Map recruitment and vulnerability, consent versions and process, privacy notices, inclusion and exclusion, medical care and compensation, randomization and unblinding, safety surveillance and serious-event escalation, product accountability, sample collection and storage, withdrawals, protocol deviations and continuing ethics oversight.

Which data, genetic-resource, and international rules apply?

Inventory source data, case-report forms, imaging, genomic and other sample-derived information, identifiers and sensitive personal information; identify systems, access and vendors, foreign control or collaboration, export or open access, human-genetic-resource approval, filing or prior report, PIPL impact assessment and transfer path, retention and destruction.

Evidence to organize first

• Protocol, amendments, investigator brochure, statistical plan, regulatory and ethics submissions and approvals, registration, sponsor-site-CRO-laboratory contracts, delegation, qualification, training, insurance and monitoring plan
• Consent and privacy versions with subject-level records; recruitment material; screening and enrolment logs; medical and safety records; investigational-product accountability; sample chain of custody; deviation, adverse-event, compensation and ethics-reporting files
• Data-management and validation plan, source and audit trails, access reviews, query and change records, database lock and analysis files; sample and data-flow map; human-genetic-resource classification and approvals or filings; cross-border assessment, agreements, security controls, retention and destruction proof

Official orientation sources: Good Clinical Practice for Drug Trials · Human Genetic Resources Administration Regulation (2024 revision) · Personal Information Protection Law overview. Source check: 8 October 2026.