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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 plan
Do 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? -
I experienced monitoring clinical studies. The projects I was involved in has a very well-established electronic data capture system. The software belongs to Oracle company. There are audit trails in every data point and query generated in the system. Each site staffs and the monitors have a different account with a password. The password is required to be changed every 90 days.
In terms of edit check and logical check, there is a system called “autoquery”. This would be generated if a particular data point seems illogical. Data entry staff need to answer the query and correct it, if applicable.
As I am a field monitor, I’m not quite sure about the data backup and recovery plan. Speaking in general, I believe there is an established plan for data backup and recovery plan like other systems. -
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After I segmenting the image data, I got them in .csv and then I analyse it using R.
To think about it again and try to compare the lab results with the clinical data
-Auditing, we don’t have it. We have only safety auditing.
-User authentication and access control level. Well, I guess that anyone in my workplace can use the computer I use with their own username and password. But not sure that they can see my data in drive D. Anyway, people from outside the workplace cannot get in easily because they must have the card to access.
-Audit check and logical check. I have another colleague to proof-reading my code.
-Data backup and recovery plan. Sadly, we don’t have a plan for this. I should have external hard disk to store another copy of my results.-
That’s great you used R in your analysis! Did you use any R packages that were specifically designed for biological applications?
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I was involved in a clinical trial study that use OpenClinica as their database management. It has all the above-mentioned processes: audit trial/time stamp, user authentication and access control level, edit check and logical check, and data backup and recovery plan. My role in that study was only to be the user and did not involve in the database development. However, before the study started I was moved to another team so I was not able to try out all of the features.
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I don’t have experience with a study in a medical or scientific context. However, in my experience working with web server logs that I mentioned last week, I have a great deal of experience with the time stamp, user authentication, and edit check elements. Server logs always have a time stamp for each HTTP request to the web server. Often, the time stamp is in UTC time, which required me to do some mental math to determine the time for the requests I was looking for because I’m located on the east coast of the United States which can be four or five hours behind UTC time depending on the time of year. We controlled user access and authentication through my organization’s help desk. The help desk would authorize users to access the database through the addition of the database using the Okta authentication and security software. With my supervisor’s request, the help desk added the database icon to my Okta dashboard, which allowed me to access the database. The database itself used the Splunk framework to store and query data. The query process in Splunk had edit checks to make sure the input variables met syntax standards. The search interface facilitated syntax adherence through an autocomplete drop-down for variable options, if I remember correctly. I assume we had a data backup and recovery plan but I was unaware of one.
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I do not have experience in clinical trial conducting. I’ve observed some vaccine clinical trials in my organisation. They just used excel to entry and save data. Compare to the course, they did not do some quality management like double data entry, access control level and logical check. Ministry of health checked random the results and found some illigical erros and the division gave some explanation documents. Therefore, those cases removed from the trials
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I don’t have any experience in clinical trial conducting but I did data collection in pharmacovigilance electronic database called ARISg system in my formal organization. There are audit trails, data backup and recovery plan in place. Every users will have a specific account and every actions made would be collect on real-time basis. Data is archived in the cloud database. I also believe the system has edit check/logic check as well as an optional workflow.
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I have no experience doing studies, my experience in data management is developing routine information systems for malaria, processes such as:
– Audit trial/Time stamp
– User authentication and access control level
– Edit check and logical check
– Data backup and recovery plan
the above process is done, and the application to store and manage data is MYSQL and I do data analysis using excel. -
My main responsibilities are implementation of routine clinical data management process including data entry, data quality checking, and preparation of eCRF. I use REDCap to conduct all of those activities. Also, I have to manage the access control level of each user according to their roles and follow all of data management process.
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During our undergraduate program, we have a activity called Computer Validation. The main objective of the activity is to digitize input data from printed manufacturing records after tablet production.
We were free to use any software, but I opted to use Excel, with expanded features through VBA (for user specific sign-in and audit trail). I was the lead on constructing the program, but I have sparse experience on coding so it was a steep learning curve.
The Quality Assurance Lead assigned credentials to every member of the production team to prevent unauthorized sign-in. Specific roles have different views (eg, those assigned on the early stages of tablet manufacturing can only view the sheets during early stages). During data inputs, there were Data Validation features in Excel which were helpful during such. For example, when the field requires numbers, we limit the field inputs to numbers only and will get an error message once letters were inputted.
During audit trail, we coded using VBA to register any form of changes in the Excel sheet associated with the logged-in account.
The program was initially tested only on a single computer but we managed to make it work through OneDrive to make it accessible on other computers, of course, after authorization from the Quality Assurance Lead.
We were only given a week to prepare the program. Admittedly, there were bugs in the system but provided the short timeline, I think we did an impressive job in building this software.
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I have experience working in Veeva Vault system for eTMF for clinical trails which implemented those processes. Veeva Vault is used to store and manage data.
• Audit trial: there is audit trails to check who uploads/modifies/access/view and when those activities were performed on the documents.
• Authentication : in order to access the system, the staff must 1) have company’s email then 2) enter the authentication code received from the system.
• Edit check and logical check : the system also shows edit checks and logical check, i.e. there are the 1) reveived date and 2) document date. The received date of the filed document must not be before the document date itself. If fails to follow this concept, the auto pop-up message will show and prevent me from entering the illogical date.
Data backup and recovery plan : these are present on the system, the essential trial documents in the already closed-out studies are archived for 15 more years. -
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I don’t have experience in conducting or doing clinical trial or any research.
But I would like to share my experience when I conducted database for Covid-19 Vaccination while I was working for a private hospital.At that time we used an electronic form as a main data collection method but the data was entered directly by patient and some was also entered by our officer. We design our system by using all of those steps including Audit trial/Time stamp, User authentication and access control level, Edit check and logical check, Data backup and recovery plan. The system worked well with some non-critical problems.
Unfortunately,we didn’t use ready to use software. We build our own software and data was managed by using SQL.
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