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Dear teacher,
Thank you for your respontation. Regarding to the size of the map, after setting up the map sacle to 5,500,000 resulting in the map fig. is avilable. The link of the capture screen
https://drive.google.com/file/d/1KhgYOt4HWQz0GEZQCPWS9LxOpZqlGZ6Q/view?usp=drive_linkThank you
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Please provide suggestions to improve your friend’s CRF.
According to screening visit, This CRF is different from I ever see that your CRF consist of only inculsion and exclusion citerials. Actually, this visit have to contain general data which will be further retrieved by the author. For example, Age and gender. Additionally, “_ _/_ _ _/ 20-_ _ (DD/MMM/YYYY)” which migh be not commonly used, but it sill work. In part of the enrollment, Date was lebel as (DD/MMM/Y) that not correct. For the female who not only give information about precnancy which should be separated from gender section. However, This CRF was well done in part of vacination test. So, I suggest that you have to observe other CRF to improve the part of screening or others.
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Please provide suggestions to improve your friend’s CRF.
First of all, I wold like to commend that this CRF is consist of more detail with good separation, which maybe good to get more data. However, it migh lead to take time for data collection. In part of screening, I suggest that CRF cold be added study site ID, and gender that following their study design. Moreover, size of charactor such as “dd/MMM/yyy” that have to consistant. Another part is enrollment, regrading to vaccination history which redundant information from screening visit. Although one heading of enrollment was missed, I still suggest that you well done. However, I never design CRF for vacination trial. Overall, this CRF was well done, but some point have to consider that important to add for save time or friendly use.
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Can you give me 1 example about the benefit of having data standards for clinical research?
Data standard for clinical research is useful for worldwide understanding. Once everyone do the clinical research with their own standards maybe resulting in we can’t well compare and interpret those research. So, we can say that Data standard for clinical research facilitate us to easily do the research.
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To ensure data quality and integrity, the data management process should have the following process.
Audit trial/Time stamp
User authentication and access control level
Edit check and logical check
Data backup and recovery planDo you have experience conducting a study (or have seen other study projects)? Do those projects have implemented these process? Which computer software that you/they use to store and manage data?
The research project that I was co-author was done follwing those process. However, I not much understand about program or sofware because my team employed a programmer to constructed software to collect the data. So Audit trial/Time stamp might be checked by some author and programmer team. In term of User authentication and access control level, programmer created website to present all raw data and data summary that only my team can ascess. Then is Edit check and logical check, maybe my sofware was new resulting in data error was showed a lot. Programmer edite and update the program againt in several time. The data were backup in server that was bought.
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Topic discussion 2
Based on your experience in data collection/management, which steps in the data management workflow that you have done and have not done?
Regrading to my project, it was a big data collection which consist of almost of workflow step such as Protocol dicussion, Data desing, Data acquisition (paper base), Data collection development, Data managment plan, Database access control, ect. Although I had experiance in all of steps, I had done only some part of step because there were many member jioned to work. For exsample, database setup that I also attented meeting but the one who did it was a programmer. So, I maybe can say that I have not done the edit checks programming, data entry and processing, study data archive and data base lock/security steps. My reseach had not done the data standard managment, SAE reconciliation and external data merging.
If you have a chance to go back, which steps that you should have done it to improve your project?
If I can improve the project, I will chang the CRF formate because it still doesn’t really work in all of steps or areas of study, resulting in other steps were diffical to manage. -
Could you share your experience on data collection?
My purpose of data collection was for research that was a primary data collection. The method to collect the data was done by paper-based. According to the subjects were old participants at remote areas, the interviews-administrated were used. There are many problems occurred because my data was collected from four provinces that my team have to communicate with local staff to manage the participants and also collect the data following my research objective. The wrong communication often occurred leading to data drop out.
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