Table 1.

Responsibilities and tasks of clinical research nurses.

Order number	Classification of responsibilities	Work tasks	Basic work	Before start-up	Start-up phase	Project implementation	Close-out stage
						Screening/enrollment/visit/follow-up
1	Facilities management	•Confirm the routine equipment maintenance and calibration work of the institution	√
		•Obtain the annual quality inspection report of common equipment in time	√
		•Confirm whether the equipment required for project implementation is complete		√
		•Confirm with PI and the sponsor whether additional equipment is required according to the project requirements		√
		•Manage the project specific equipment provided by the sponsor according to the hospital regulations			√	√
		•Return the special equipment provided by the sponsor					√
2	Training and education	•Complete training on laws and regulations related to clinical research	√
		•Understand clinical research methods and basic knowledge of Statistics	√
		•Gain insights into the basic knowledge of disease medicine related to clinical research	√	√	√	√
		•Have communication, foreign language, and computer skills	√	√	√	√	√
		•Improve the necessary nursing professional knowledge and skills for clinical research	√			√
		•Project training (eg, program and SOP)		√
3	Project planning and implementation	•Engage in a wide variety of research meetings, master clinical research requirements, and follow-up research progress		√
		•Assist PI in formulating/reviewing research protocol, informed consent, CRF, and other documents	√	√
		•Project initiation application and follow-up		√
		•Ethics committee review application and follow-up		√
		•Human genetic resources application and follow-up		√	√	√
		•Contract review application and follow-up		√
		•Assist investigator to organize research teams according to project needs		√
		•Work coordination and application of relevant departments in the research center			√
		(eg, pathology examination imaging and pharmacy)
		•Assist in preparing, organizing, and holding kick-off meetings			√
		•Confirm that the members of the research team have been trained and authorized		√	√	√
		•Contrive and continuously optimize the project implementation process		√	√	√
		•Develop and continuously optimize worksheets			√	√
		•Assist the research team in discussing drug combinations and treatment plans				√
		•Record and report the scheme violations and continuously optimize the implementation process				√
		•Submission of annual reports24				√
		•Submission of protocol and revision of informed consent			√	√
		•Review/submit CRF, drug test report, IB, and other project-related documents				√	√
4	Subject management	•Assist in the recruitment of subjects				√
		•Assist in screening subjects				√
		•Informed consent in the scope of professional qualification				√
		•Check the eligibility of subjects				√
		•Complete the randomization/enrollment procedure of subjects				√
		•Appointment and arrangement of visit procedures (eg, examination, treatment, and follow-up of subjects)				√
		•Offsite communication and follow-up via telephone or other means of communication				√
		•Tracking and recording of combined treatment and medication of subjects in the study period				√
		•Carefully observe the tracking and recording of the subjects' condition changes				√
		•Survival follow-up				√
5	Subject education	•Instruct subjects to comply with the protocol for follow-up				√
		•Instruct the subjects to use the trial drug				√
		•Educate the subjects on prohibited drugs and treatment				√
		•Instruct the subjects about diet, exercise, and other disease-related knowledge				√
		•Instruct the subjects to use the relevant equipment for the test				√
		•Instruct subjects to complete diaries and questionnaires				√
6	Safety monitoring	•Finding and observing adverse events of subjects				√
		•Assist in collecting, reporting, tracking, and recording security incidents				√
		•Assist researchers in coping with adverse events				√
		•Provide adverse event nursing guidance and education to subjects				√
		•Timely report SAE				√
		•Timely submission of SUSAR to ethic committee				√
7	Investigational drug management	•Assist in the management of the central pharmacy/satellite pharmacy of the experimental institution		√
		•Ensure that the storage environment of the test drug meets the requirements			√
		•Receipt, storage, distribution, and return/destruction of investigational drugs			√	√
		•Receiving, configuration, and use of investigational drugs				√
		•Storage of investigational drugs in clinical departments, warehousing registration, and return				√
		•Drug dose calculation and verification				√
		•Instruct subjects to fill in medication records			√	√	√
		•Medication compliance management				√
		•Train the executors of the investigational drug (dispensing and injection) according to the program			√	√
		•Collect drug test reports			√	√
		•Timely replenish the inventory of investigational drugs in the validity period			√	√
8	Investigational device/reagent management	•Ensure that the storage environment of investigational devices/reagents meets the requirements				√
		•Receive, manage, and return investigational devices/reagents according to hospital management requirements			√	√
		•Requisition and use of investigational devices				√
		•Receive training on the use of investigational devices/reagents			√	√
		•Inventory management, stock replenishment application, and warehouse in and warehouse out registration				√
		•Counting, destruction, recycling, and recording of test reagents					√
9	Sample management	•Develop sample management process		√
		•Receiving, checking, using, and warehousing management of sample-related consumables			√
		•Sample collection/collection, processing, storage, transfer, and warehousing registration				√
		•Records of sample management process				√
10	Data management	•Discuss and confirm the source data File of the research project with the researchers			√
		•Issue, recover, and save diary cards and questionnaires				√
		•Fill out the CRF				√
		•Answer data queries				√	√
		•Research-related data copy and transmission				√
		•Complete first level quality control
		•Ensure data authenticity, logic, and other quality management work				√
11	Contracts and funds	•Project budget		√
		•Contract review, submission, and signing		√
		•Fund injection and expenditure management			√	√
		•Reimbursement and management of subjects' related expenses				√
		•Collect and save bills related to project funds				√
		•Accounting of project funds					√
12	Essential documents	•Confirm essential document management requirements	√	√
		•Investigator folder preparation			√
		•Collect, save, maintain, and update research process documents, and original data documents				√
		•Filing and return of research documents					√
13	Material handling	•Management of project-related materials (eg, document supplies and consumables)			√	√	√
		•Confirm and supplement corresponding materials with the sponsor in accordance with the research requirements		√
		•Manage materials according to hospital regulations, report registration, as well as use records			√	√
		•Regularly check inventory and effectiveness and timely replenish			√	√	√
		•Timely liquidation and return of relevant materials					√
14	Communication and coordination	•Coordinate and communicate with institutional offices and ethics committees		√	√	√	√
		•Coordinate and communicate with relevant departments within institution (pharmacy, finance, information, inspection, and other medical technology departments)		√	√	√	√
		•Coordination and communication with the research team		√	√	√	√
		•Be responsible for coordinating and communicating with the sponsor and contract research organization		√	√	√	√
		•Coordination and communication of supervision, inspection, internal inspection, and verification			√	√
		•Find and deal with operation problems in time			√	√
		•Evaluate the operation process and improvement of the test institution (system construction)	√	√	√	√
15	Research-related caregiving	•Research-related nursing physical examination, treatment, medication, and care				√
		•Condition observation and psychological care				√
		•Health education for patients and their families related to diseases and research				√
		•First aid care				√
		•Research ward nursing

PI, principal investigator; SOP, Standard Operation Procedure; CRF, case report form; IB, Investigator’s Brochure; SUSAR, suspected unexpected serious adverse reaction; SAE, severity adverse event.