OBJECTIVE： To provide the suggestions for the smooth implementation of record-keeping system in drug clinical trial institutions. METHODS： The obstacles in the implementation of the record-keeping system of drug clinical trial institutions were analyzed to put forward countermeasures according to search related announcement， document and literature. RESULTS & CONCLUSIONS： In the process of implementing the record-keeping system of drug clinical trial institutions， there are mainly deficiencies in the relevant laws and regulations of the record-keeping management of drug clinical trial institutions， the supervision of the process of drug clinical trial， the unclear functions of regulatory bodies， lack of hardware and saftware status quo that clinical tral institution construction in non “third grade class A” hospitals， the weakening of the internal management of drug clinical trial institutions， and the bidders’ demand for clinical trial institutions concentrated in a few large hospitals after the implementation of record-keeping system. Based on this， the author suggests that the relevant state departments should improve the Drug Administration Law of the People’s Republic of China as soon as possible and promulgate relevant regulations and implementation rules to clarify the relevant regulatory bodies and their functions （such as State Drug Administration， in conjunction with the State Health Commission， formulates relevant laws and regulations for the supervision of clinical trial institutions； National Medical Products Administration is responsible for establishing an evaluation index system for drug clinical trial institutions； provincial drug administration and other departments are responsible for the evaluation criteria， inspection rules and process supervision）. The government has established an internal and external linkage mechanism to actively build and maintain the effective operation of drug clinical trial institutions. The internal management of clinical trial institutions can be strengthened and the division of labor can be rationalized by means of leadership attention， formulation of internal charters， strengthening internal training and inter-agency communication and learning； according to the technical level of medical and health institutions， differentiated services was provided to attract bidders； the capabilities and types of the institutions in the record-keeping system of National Medical Products Administration should be classified and publicized； bidders should be encouraged to select suitable institutions for drug clinical trials so as to guarantee smooth implementation of record-keeping management in drug clinical trial institutions.