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What are the key tasks in the four stages of clinical research project schedule management?
On August 30th, the management of the project schedule is divided into four phases: project planning, project initiation, project implementation and project completion. Project control is throughout the project life cycle.
From the moment of undertaking the project, the project manager will start the running mode and keep up with the progress. In the planning phase of the project, each time point should be planned; in the implementation phase, follow-up actions should be taken at each time point and measures should be taken to ensure that the project can achieve the intended goals at each time point and in the planned Time ends the entire project. These require project managers with proven project management experience and capabilities.
Step 1 - Planning stage
Before the project begins, the project manager and the company's management determine the overall plan of the project, including the financial budget, team composition, and project completion time. “The terracotta warriors are not moving, the grain is first,†the project manager needs to plan the manpower, material and capital needed from the beginning to the end of the project, rather than having insufficient staff or insufficient funds in the middle.
For clinical research on new drugs, special attention needs to be paid to the supply of drugs . Because the yield of new drugs is often limited, the scale of clinical research needs to match the production capacity of new drugs. Don't think that as long as you have enough money, you can solve all the problems. Many of the problems in clinical research are not solved by money. At the beginning of the project plan, there should be a full consideration of this.
Based on the actual needs of the project operations, the project manager accurately estimates the overall time the project is completed and the time required to reach each node in the project life cycle. According to the schedule plan of the project manager, the management of the company expects the time of product launch, coordinates the division of labor, quality control, registration, medicine, marketing, sales and other departments to carry out the division of labor and cooperation, and starts the marketing promotion before the product goes on the market. The foundation for marketing and sales after the listing of drugs.
Step 2 - Startup phase
The project start-up phase is the phase from the start of the project to the start of the center. Some companies have established a dedicated team (Study Start Up team, SSU for short) to take charge of this work. It is divided into the following 7 steps:
1. Project kick-off meeting (Kickoff Meeting )
The project start-up will be a landmark event for the official launch of the project. This will be attended by the manager of the project manager and various collaboration departments (medical monitoring department, pharmacovigilance department, data management department, statistical analysis department, central laboratory, drug supply department, etc.), and the company's leadership will also attend the meeting according to the situation. . Auditors generally do not need to participate in the project start-up meeting. The purpose of this meeting is to announce the overall project plan, and to confirm that the project personnel equipment and materials are available and the project can be started.
If the project is outsourced to the CRO by the sponsor, the time of the start-up will need to be confirmed with the sponsor in advance, as the project will be incurred once the project is initiated. If the necessary conditions for starting a project are not available after the start-up meeting, unnecessary expenses will be incurred. But sometimes the sponsor can accept these extra expenses in order to speed up the progress, and that is the exception.
2. Feasibility Study (FS)
3 , the researchers screen
Sometimes the feasibility study is combined with the screening of the investigator. Through feasibility studies and screening of researchers, determine which researchers are participating in this clinical research project. The time required for this process is determined by the project manager based on experience. In order to shorten the total time of the project, some feasibility studies can be started before the start-up meeting. For those who have worked well together, the process of screening can also be simplified.
4 , ethical approval
The project manager prepares the materials according to the requirements of the central ethics committees to obtain the approval of the ethics committee. The project manager estimates the time of approval of the ethics committee and needs to know the frequency of meetings of the ethics committee. It should also be considered that two or more meetings are required to obtain an ethical approval. Some hospitals require the ethics committee of the lead unit to approve the ethical approval of the hospital; some hospitals have to go through the hospital's clinical research institutions for approval before ethical approval.
5 , the genetic approval document
If it is a foreign-related enterprise or a CRO company, it will also need to obtain the approval of the genetics office. Although the approval of the Genetics Office is becoming more transparent and simpler, it usually takes two to four months to obtain approval. The project manager needs to make a good plan for this time.
6 , contract signing
Thereafter, enter the stage of signing a contract with each hospital . For the details of the contract amount, responsibility and other details, often each hospital has its own special requirements, need to negotiate between the hospital and the sponsor several times, and need to participate in the dual method department. The project manager should not be too optimistic about this time estimate.
7 , the researcher will
After signing the contract, organize the researcher. Researchers will conduct project-related training for researchers involved in clinical research. After reviewing the necessary documentation for the clinical studies in each center, you can make an appointment to start the meeting.
Although ethics submission, genetic submission, contract signing, etc. can be carried out during the start of the project, it usually takes about 6 months, and some projects or hospitals take longer.
Step 3 - Implementation phase
The launch of the project at each center is marked by the start-up meeting of each center. Before the start of each center, some necessary documents for clinical research need to be verified. The project manager confirms that the center has the necessary conditions for conducting clinical research before the start-up meeting can be approved.
Generally, the clinical research drugs will be delivered to the hospital after the initiation meeting. After the initiation meeting, the investigator is usually required to start the screening of the subject immediately. The project manager will ask the centers to complete the first patient's enrollment after the initiation meeting. At the same time, the project manager will generally ask the auditor to conduct the first audit within two weeks after the first patient is enrolled. It is a key element of schedule control to start as soon as possible, supply research drugs as soon as possible, and conduct the first inspection as soon as possible.
The time from the first case to the last case is the enrollment time of the entire project. Enrollment time is often the most difficult to grasp in project schedule management, because it will be affected by many factors, such as the indications specified in the program, the criteria for inclusion and exclusion, the number of cases and the number of centers.
The project manager can take appropriate steps to adjust. For example, the enrollment time is proportional to the difficulty of enrollment and the number of cases, but inversely proportional to the number of centers. Increasing the number of centers will shorten the time of enrollment, but increasing the number of centers will significantly increase the cost of research and increase the difficulty of quality control. Therefore, at the beginning of the project, the project manager needs to balance the various risks and plan the final patient enrollment time. The plan for the enrollment time needs to be continuously adjusted during the progress of the project. If the actual enrollment time is found to be longer than the planned enrollment time, the enrollment strategy should be adjusted in time. However, there may be cases where the actual enrollment time is shorter than the planned enrollment time. The project manager should analyze the reasons for the too fast enrollment to ensure the quality of the enrolled patients and even take measures to control the enrollment speed.
From the time the subject is enrolled to the out-of-group is the time at which a subject completes the entire medication and observation, commonly referred to as treatment time. This time is determined according to the plan. However, for clinical studies of tumors , the chemotherapy cycle experienced by each patient may be different, and the patient's survival time is different, so the treatment time will be different. The project manager determines the average time of the treatment period based on his or her own experience to estimate the time at which the project ends. At the end of the estimate, be careful not to overlook the time required for safety follow-up and survival follow-up.
Some studies will conduct an interim analysis. Interim analysis generally does not affect the overall progress of the project. However, if the interim analysis leads to statistical intervention and the total number of cases is adjusted, it will affect the overall progress of the project. This should be considered when developing a project plan.
Step 4 - End stage
After the last patient completed the clinical study, he entered the stage of database locking and closing. The project manager negotiates with the data management department the time required for data lockout and plans to close the center. The length of this time requires close coordination between auditors, researchers and data managers. The auditor needs to urge the researcher to complete the answer to all data questions in a timely manner.
After the database is locked, enter the statistical analysis and clinical research summary report stage. The project manager and the statistical department and the medical writing department confirm the time required to write the statistics and summary report. For a clinical research project, the finalization time of the summary report is the time at which the project ends.