5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?  

The Ethics committee is responsible for determining if the qualifications and experience of the investigator meet the requirements of clinical research.

http://www.ircip.cn/web/993898-1127965.html?id=26645&newsid=2638885

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?

The PI must be based in China.

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

Yes, China allows the use of eICFs. 

Electronic signatures in general are regulated through the Electronic Signature Law which defines an Electronic signature as:

“Data in electronic form contained in and attached to a data message to be used for identifying the identity of the signatory and for showing that the signatory recognizes what is in the message.”

https://www.wipo.int/edocs/lexdocs/laws/en/cn/cn105en.pdf

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

There is no specific requirement for the ICF to be audio-visual. The required elements are as below:

Informed Consent Form Required Elements

• The study purpose, procedures, and duration of the trial
• Any expected risks or discomforts to the participant
• Any expected benefits to the participant; if no benefit is expected, the participant should be informed of this point
• The participant’s responsibilities
• The approximate number of participants involved in the trial
• Those aspects of the trial that are experimental
• Treatment available to the participant as well as important potential risks and benefits associated with this treatment
• The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks
• The nature, form, and extent of compensation for participation
• Any expenses the participant needs to pay to participate in the trial
• The extent to which confidentiality of records identifying the participant will be maintained, and a statement that, when necessary, the sponsor, the EC, the National Medical Products Administration (NMPA), and drug authorities in the provinces, autonomous regions, and municipalities may be required to review participant data
• Any treatment and corresponding compensation the participant can expect to receive in the event of a trial-related injury
• The participant’s rights, including that participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
• Precautions and protective measures for the participant before and during the research
• The foreseeable circumstances and/or reasons under which the participant's participation in the trial may be terminated
• Contact information for the sponsor and investigator in the event of participant problems or injuries related to the trial
• Basic information about the researcher and qualification of the research institution
• That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant’s identity will remain confidential
• That the participant or the legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant’s willingness to continue participation in the trial
• When appropriate, the EC may require this additional information: whether the research may put the participant at risk but the risk is not currently foreseeable; researchers can terminate a participant’s participation in the study without their consent; new major discoveries during the research will be provided to the participant; and whether there is a potential conflict of interest
• If applicable, how biological samples will be handled

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

The China Personal Information Protection Law (PIPL) is the new data privacy law in China.

https://www2.deloitte.com/cn/en/pages/risk/articles/personal-information-protection-law.html

5.6 Does local regulation allow Home Healthcare Professional Visits (HHCP) in decentralized and/or hybrid studies? If yes, explain if there are any specific requirements to fulfill these obligations.

Yes. Home visits may be considered if patient safety can be assured and there is no impact on the quality of the data generated. Investigators need to employ measures to confirm the identity of the patients during visits, and that patient privacy and safety are maintained as described in the Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation).

5.7 Does local regulation allow Direct-to-Patient (DTP) study product delivery (such as home delivery) in clinical trials? Are there specific requirements to fulfill (e.g., acknowledgment of/signature for the product by the patient, etc.)?

According to Technical Guiding Principles for the Implementation of Patient-Centered Drug Clinical Trials (English Translation), direct-to-patient supply may be used to improve the convenience for patients. Where DTP supply is undertaken, the nature of the medication, the route of administration, and patient safety need to be taken into consideration as well as the storage, retrieval, and disposal of the medication. 

5.8 If a clinical study involves the study product as OTC and this is provided via pharmacy/Amazon, etc., are there any specific regulations for IP management that need to be followed?

Please refer to Section 5.7 above. 

5.9 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

There are no detailed regulations around what can be compensated/paid upfront. This needs to be discussed with the local PI and reviewed by the local EC.

Patients may pay the cost for the product in RWE but cannot pay the cost for the product in an interventional study, such as phase I/II/III. Patients should not end up out of pocket for medical examination and other related costs and may have some compensation, for things like travel costs.

5.10 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

The ICF should contain a statement with a description of the nature, form, and extent of compensation for study participation. The ICF should also inform the participants if they will need to pay for any expenses in order to participate in the trial.

The ICF should contain a statement with a description of the anticipated prorated payment to the participants that is reasonably expected for participation in the trial. Any compensation or incentive to participants must not be so excessive that it may unfairly influence participants, or cause them to overlook important facts and risks.

5.11  Specific labeling requirements for clinical study product

The main contents of the label should include:

• Product name, model, and specification
• Registrants or recording applicants’ name, home address, contact information, and after-sales service firms. For the imported medical devices, it should state the legal representatives’ name, home address, and contact information.
• Medical device registration certificate number or record number.
• Manufactures’ name, home address, production address, contact information, and production license number or production record voucher number. For the applicants who use the sub-contract production, they have to mark the sub-contract production companies’ name, home address, production address, and production license number or production record voucher number.
• Date of production, term of use, or expiration date.
• Power connection condition and input power.
• Graphics, symbols, and other relevant content should be marked according to the product characteristics.
• Required warnings and notices.
• Special storage, operation condition, or explanation.
• If the medical device will destroy or have a negative effect on the environment, the label should include warning symbols or a Chinese warning explanation.
• If the medical device comes with radiation, the label should include warning symbols or a Chinese warning explanation. Due to the size or location limit of the medical device label, it shall label the product name, model, specification, date of production, term of use, or expiration date. And it shall state on the label that the details will be included in the product manual.

https://www.cirs-group.com/en/md/medical-device-labeling-requirements-in-china

5.12 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

The most important single document for importation is the Import Permit issued by one of the provincial and municipal drug authorities, for example, the Beijing Food & Drug Administration (BDFA). Many specialist courier companies can assist with this process. Once the application has been made through one of the FDAs, then all arrangements should be made to import through that authority rather than another port. This simplifies the clearance process.

See below for more details of the process:

https://www.outsourcing-pharma.com/Headlines/Promotional-Features/China-and-the-Process-for-Importation-of-Clinical-Trial-Drugs

5.13 What is the turn-around time to get an import permit?

It takes up to 2 weeks before an automatic import license is approved. An automatic license is granted if the goods being imported are Permitted Goods.

https://www.export2asia.com/blog/import-license-china/

Applying for an Import License in China

It is relatively easy to apply for an import license, but it requires close coordination between the Chinese importer and the exporter. Interested parties need to download and accomplish a form from the MOFCOM website. Once it’s filled up and you submit all required documents, the license should be ready in two weeks. It is free of charge.

Information Required for Acquiring an Import License 

The information listed below is required from the importers and exporters involved in the transaction to complete the application process.

• Name/company number of importer
• Import license number/expiry date
• Importer’s consignee in China
• Country or region of exportation
• Country or region of the product’s origin
• Terms of trade and foreign exchange
• Place of clearances
• Uses, description, and product code of the goods
• Product’s specification, unit, quantity, and price
• Other supplementary details, and
• Issuing authority stamp carrying the text ‘automatic import license’ in Chinese along with the city of issuance.

Importing products into China almost always requires an import license.

5.14 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

Yes, local authority allows this action. The vendor should have the license/qualification, get authorization from the sponsor prior to destruction, and make a detailed record which should send a copy to the sponsor as well.