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Hi Karina and Kansiri,
Thanks to you both for all the comments.
Karina, great suggestion for 24 hours format for time, the checkbox, and screening ID and subject ID. I like and learn a lot from your CRF.
Kansiri,
1) Yes, I agree. Screening date would be more suitable than start date, less confusing.
2) Yes, I saw comments from ajarn that added “25” in the birth year.
3) To be honest, I did not think of the screening ID. My plan was if the subject is not eligible, they would fail to get subject ID and it will be left as a blank. Haha. -
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This form is superb with very neat format, therefore easy to read. The instruction is concise.
Anyway, I have some question. I don’t have any experience on clinical data. It would be great if you can share the experience with me.
-I see you put subject initials in the form. I guess that it would help us to track the accuracy of filling in the form. However, won’t it expose subject’s personal details too much?
-If the subject does not take urine pregnancy test, should the subject be ineligible?
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I like the format. It is clear and easy to read. Also, I think it is a good point whether female participants are on birth control before we will provide birth control measure to them.
I have no experience on clinical data and designing CRF. I just would like to ask or share an idea.
– In the exclusion criteria, I am wondering whether it is possible that a participant would not remember their own vaccination history or their illness that is alike influenza? I think here we may need a choice of not certain.
-The screening page and enrollment page will not be bound together, right? I guess from the page number. I hope there is a log book for recoding the subject ID and subject randomisation number. And why don’t you also use subject ID in page of enrollment?
-It is randomised observed-blinded study. I am not sure that the type of groups can be recorded here or in a log book.
-Also, from the protocol this study does not vary the volume of the vaccine. So, I am not certain that we need to record here.
-Is it possible that the HAI titers can go up to 1:100 or more? If so, that means you may need more box(es).
-I think the same as Sri, you may need vital sign and medical history sections.
-Is ‘randomisation group’ and ‘type of vaccine administered’ repeated each other?
-No anatomical location where the participant got the vaccine recorded. -
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I don’t have any experience on clinical data. I have done only basic research. The logically order of the steps are quite similar. There are some steps that are in both clinical and basic research, but some are not.
The similar ones are
-Protocol discussion and data design would be the same when we plan and design the experiment out. What is the control? What is the method or technique to use?
-Data entry and processing would be equal when we are conducting the experiment and collect the results.
-QC and QA would be the same as when we analyse the results data. We focus on the control and see how it shows the results. If we are testing some drug or reagent at different concentrations, we should see some constant trend or no change. But definitely not, up and down results. This step in basic research we will do it together with data manipulation and analysis.
-Finally, we present our results same as data report.In basic research we are not concern much about database lock/security. We depends on the security of our work place only. We protect our data and properties from people outside.
Another thing that I think we less concern in basic research is archiving and backing up the data. I should be concerned about it more from now on.
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1) I don’t have experience in any clinical data. I always do basic research in a laboratory. Currently, most of my data are from images of the bacteria infecting cell line. The purpose is for research.
2) Primary data collection.
3) Method: I put the bacteria into a cell culture, incubate them for certain time point, fix and stain the cells and bacteria, image in high-throughput manner and analyse the data.
4) Some time the microscope was out of order. Some time because of new method for staining the samples, I had to optimise the method. Some time because the time point was too long and the cells were overgrown and became multi-layers. Some time the cell culture was treated with some reagent and it could not survive. -
I don’t have experience on clinical data and I have never used both Bayesian and frequentist statistics.
Therefore, I don’t have clear picture on these statistics. After read the paper, I have a few questions and would like to discuss with you.
First one is from the first page of the paper, nearly at the end of middle paragraph at the right side. He stated that “If the prior and posterior probabilities come from the same statistical distribution family, they are called…”
Compare Bayesian statistic with t-test and other common ones, we usually test the distribution of the input data which is equal to prior probability. Anyway, the outcomes from t-test would be just p-value, whereas Bayesian generates probability of probability. The questions are:
1) why we would like to know the distribution of posterior probability?
2) is it matter if the distribution of prior and posterior probability the same or not the same type?Next questions are from the second page, the second last paragraph at the left side. He stated that there is no single, prescribed and well-defined method for choosing a prior. The consequence of that is people use different priors and thus obtain different posteriors and make different conclusions.
Here I question (3) how we know which prior is suitable for our study? or
(4) If we try different priors, how do we know the posterior is correct? Is there any method for validate the posterior? -
Hi. My name is Yanin. I’m a postdoc scientist at Mahidol-Oxford Tropical Medicine Research Unit. My experiment is at cellular levels in culture slide and observe bacteria to infect the cells. I definitely need statistic tools for comparing the differences between experimental groups.
I have studied statistic during Bachelor’s and Master’s degree and learn by reading and googling again when I have to use it for analysing the data so far. Recently, I start using R and some statistic packages (of course, I google to learn about them). Sometimes I have questions that I cannot find the answer. I feel not confident that I am doing it right but at the same time I could not tell what’s wrong with it. So, I am glad that I found this course.
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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.
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