Week 2 Topic Discussion 1 : GCDMP

[Saranath]

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?

[Zarni Lynn Kyaw]

I would like to showcase two projects that I have worked on in my experience.

1) The People’s Health in Southeastern Myanmar: Results from a Household Survey and the Way Forward where we collect data from 486 households
2) Ethnic Health Organizations in Myanmar Readiness to provide Essential Health Services and Plans of Action where we collected data from 5 health organizations

The outcomes of these projects are valuable in providing much needed data for the underserved ethnic population in Myanmar. However, I have to admit that we faced some challenges in ensuring data quality and integrity in the data management process, such as:

– Audit trail/Time stamp: All of the raw data were in paper-based format and in the case of the second project, we did not have a proper audit trail/time stamp, because we lacked the necessary knowledge and skills. We did not have a qualified data manager to standardize the data collection, recording and storage. We used Google Drive to store our data. Data collectors just uploaded everything into the same Google Drive and I, as the researcher at that time, had to piece all the data together. Although we could check who accessed the folder and when using Google Drive’s administrator features, we did not do so regularly.

– User authentication and access control level: Only people with my organization’s email could access that Google Drive, but it was still possible for someone to download the folder and share it with others. We tried to limit access to certain people, but there was still room for improvement.

– Edit check and logical check: For the first project, we applied edit checks and logical checks when we cleaned the data, but we did not perform double data entry, due to limited resources. For the second project, we used CommCare by Dimagi, which reduced the use of paper-based methods, but we could have implemented better edit checks.

– Data backup and recovery plan: Google Drive automatically backed up our data, but after the data cleaning process was completed, we saved a copy onto a USB drive. However, we did not have a qualified data manager or any health informaticians, so we were unaware of some best practices at that time. Now we have restructured our M&E department and integrated it with our health systems strengthening team. We hope to improve our data management process in the future.

What computer software did you/they use to store and manage data?
We used CommCare by Dimagi before, but due to budget constraints (it cost 10,000 USD per year as subscription fees), we are in the process of developing our own system using Javascript for the front end and Oracle Systems for the back end. It is currently in testing.

[Saranath]

Sound great!

[Wichayapat Thongrattana]

I suggest you should consider to keep the data in the google sheet as it is easy to use, user friendly, and provides several feature such as real-time team editing, migrate function, edit log, and several data management plugin. Moreover, there is also the javascript library that can save the data into google sheet.

[Jintana Pankam]

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?

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.

[Saranath]

Thanks for sharing. For future projects that you will be the PI, you might need to consider these issues and discuss with programmers to make sure that all of these steps are done appropriately.

[Wichayapat Thongrattana]

I would like to share my experience as data manager on landslide data hub project. The purpose of this project is to create an online data storage system for keeping the data related to landslide disaster such as rainfall, soil type, and geography. The web-based record form was construct according to the list of variable and requirement provided by project manager. Database system was established based on MySQL software to keep all of those data. The data management webpage was also implemented but secretly and can be only used by me. I would say that in this project there was neither perform audit trial nor time stamp sine I never deal with physical document. The authentication and access control level in this project was performed by setting up the new database account with specific database accessibility. More over, the login page was created for security. The edit and logical check were implemented in conditional statement and embedded in the webpage, so some input form will show or hide upon the corresponding choice. The backup plan was based on Simple Recovery Model to reduce size of backup file and the backup was performed every week.

[Boonyarat Kanjanapongporn]

I don’t have experience with clinical research involving data management processes. From the lectures, there are many problems which could affect data quality and regulation compliance from the process of data acquisition to the process of data entry. That is, the regulation or problem including entry errors, system authentication, data acquisition plan etc. Controlling the data quality might be difficult or impossible by using only human management, capable software is needed with large amounts of data and complex data management. Moreover, using software which had been designed to comply with the information system regulators such as US-FDA, would assist the data managers and also guarantee the data which is produced by trusted systems. I have researched the commercial program on the internet. There are plenty of companies offering the data management software including IBM, TrialKit etc. Functionality, compatibility and price are varied. However, I am not sure on the situation in real practice and looking forward to other friends’ comments about their experience. 🙂

[PREUT ASSAWAWORRARIT]

According to my previous research, I did not do the audit trial or time stamp because the data was collected by myself and the edit could be done under carefully check. In addition, user authentication was used as the password to access my laptop. I did the edit check and logical check. All data was checked for the data entry error. Logical checks were performed to ensure that the data are consistent and relevant. I used the Google drive for my data backup on the cloud with the sync feature, however, I made the mistake that I accidentally deleted the file on the cloud and my file on the laptop was also deleted too. So I had to do the data entry again, and it took more time.

[Saranath]

Oh! Accidentally delete the file without backup was a disaster.

[Siriphak Pongthai]

I have been participating in the clinical trials where my position was assigned to different roles depend on the clinical trial. One of the studies, I was assigned to be Pharmacist of Record (PoR). While another study, I was assigned to be Associated Pharmacist (AP). With these two different roles, access control is significantly different.

I would like to give you an example when I want to access into the clinical research management system (CRMS). The PoR was granted access into the system whereas the AP was not. In addition, by logging into the system, in addition to user and password, it needs two factor authentication for second verification process. Yet, after accessing into the system, it also shows the last success login time. Also the time stamp that you edit/add information into the query or issue.

However, for the last two processes (edit check and logical check and data backup and recovery plan), I have not involved with but in the clinical trial that conducted at my site. They have a logical check by the QA/QC department. And the data backup and recovery plan is responsible by IT department.

[Tanyawat Saisongcroh]

One of the studies that I experienced, it was retrospective study that collect the data from EHR. We used a web application called REDCap to capture the data and create database. eCRF was developed there and assigned access to specific data collectors (me and another colleague). This REDCap has a built-in audit trail that logs all user activity, all pages viewed by every user and changes made by users. We need an account log in for REDCap and project manager has to add you in that particular project so that you can enter the data. In the eCRF developing process, we can assign some conditions to create some level of automated edit check, such as value range, if../condition. We didn’t do a logical check. When we finished data collection, we exported into Excel sheet that kept in a limited access shared folder provided by institute and managed by project manager.

[Boonyarat Kanjanapongporn]

Thank you for sharing, interesting data management process.

[SIPPAPAS WANGSRI]

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’d like to share my previous experience about research data management. In my opinion and experience, I think data backup and recovery plan are the most important. The reason why is that when something was wrong and you lose all the data, everything you’ve done so far was for nothing. I used 3-2-1 backup strategy for very important data. Here’s the brief description of what 3-2-1 backup strategy is.

The 3-2-1 backup strategy simply states that you should have 3 copies of your data (your production data and 2 backup copies) on two different media (disk and tape) with one copy off-site for disaster recovery

I find this technique as a very effective way of backing up data as well as safeguarding them. I have one copy of working data on my machine [Copy #1] (I use macOS and have its back up tool set up; it’s called Time Machine where your data is automatically backed up periodically to an external hard drive [Copy #2]). After I finished working with these data, I also uploaded them to Google Drive [Copy #3] for further use and collaboration with other team members. When my project has finished, I archived them in 1) my personal machine (and of course, Time Machine) 2) Compressed archive on google drive 3) my personal NAS (Network-Attached Storage)

This way I can make a copy of my research and lifelong work safely.

[Tanatorn Tilkanont]

I have an experience to be in a part of clinical research studies. I can see those studies involved these process, however I did not have much details about data backup and recovery plan process. I think this supported by the software.

The software that I have experiences are electronic data capture system, including Viedoc, iMedidata and ClinicalOne (Oracle).

Audit trial/Time stamp: I got a chance to be a part of user as well (for iMedidata). I can see the audit trail in the system every time when the data entered or edited. The system will show which user was performed and the time that was entered/edited.

User authentication and access control level: All the softwares that I experienced are required one account for one user. Every user must be authorized and well-trained of EDC system. Different types of user may have different access permission and limited function in EDC depends on each role in the study.

Edit check and logical check: I have a little experience on this. But I have a chance to configure the system and design the edit checks using Viedoc EDC system. The software provides some build-in functions to generate the simple edit check such as preventing future dates or setting visibility of some fields/questions. The logical check is mostly designed by using simple JavaScript code to validate data consistency within the page and across the pages.

[Myat Thiri]

I don’t have experience in data management process but I’ve seen how other people do.
Data backup and recovery plan- This step is the step that they care most because they are worried about they will lost data. They save in laptops and USB drive.
Edit check and logical check- I ask them how to do it and they admitted that they can’t check all the details and they just check some obvious errors and mostly they do skimming.
User authentication and access control level- they use excel sheet and share between the groups but not strict authentication. If someone enter the link, all the data can be seen and can be edited or can be edited.
Audit trial/ time stamp- They use time stamps in excel sheets and can be seen who edit, delete or enter the data.

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