PONE-D-23-02739Design and implementation of a quality management system for a glaucoma registry to ensure the collection of data of regulatory-grade qualityPLOS ONE

Dear Dr. Urushihara,

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Reviewer #1: Yes

Reviewer #2: No

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Reviewer #1: N/A

Reviewer #2: No

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Reviewer #1: Yes

Reviewer #2: No

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Reviewer #1: Yes

Reviewer #2: No

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5. Review Comments to the Author

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Reviewer #1: Thank you for submitting this manuscript which would be a useful addition to the literature that is accumulating on the quality assessment of disease registries that collect real world data. The focus of the work over here is to compare the quality of a registry against the criteria set by a number of international bodies for a registry to function as a suitable data resource for regulatory purposes. The authors show that their glaucoma registry ticks the majority of criteria and in the process provide a blue print that can be followed by other registries.

The manuscript would be further enhanced if the authors can consider the following points:

- can the authors provide further information on the quality assurance process - specifically, how often do they propose to perform source data checks and will those exercises as well as do these exercise need to be performed remotely or physically.

- the authors explain that the registry has protocols for data access but it seems that these are for those using the registry. They do not make it clear as to what is the protocol for data access by the wider group of investigators who may or may not be users of the registry. Its not clear as to what is the data access policy for research.

- on the point of governance, it is unclear as to who is in the steering committee and how is this managed

- data harmonisation - it seems that the registry has several uniques fields which are preclude it from data harmonisation; I think this needs some greater discussion; how were these fields created and who provided the guidance. Given that there may be several glaucoma registries in the world, did the investigators investigate the level of consensus amongst experts before embarking on the development of fields.

- it is unclear as to whether patients have been involved in advising on the contents

- training sessions - how often have these been planned for users

- I believe that the supplementary tables (esp table 2) are possibly more important than some of the figures which have been included in the main text as they constitute actual results.

Reviewer #2: 1. Please find a suitable title, because it is very poorly framed. It appears that the researcher doesn’t know how to encapsulate the entire idea in the title.

2. Reduce the overall length if the abstract and I am also not happy with the English. There is a need to improve style of writing. And also club the entire abstract and remove the headings given in the abstract.

3. The first line of the introduction is poorly written….. Disease/patient registries are……….

4. I am not even happy with the entire structure of introduction. The very important feature of an introduction is the background and the importance is missing.

5. RM is also very week and only focuses on curate clinical test and PRO findings in patients with 128 glaucoma and provide longitudinal data. How the three component approach will help in solving the problem. What is the sample design, the procedure for reaching to the target audience is also not clear.

6. Analysis, Findings conclusions are the weaker sections of this research work.

7. Kindly rewrite the entire paper

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Reviewer #1: Yes: S. Faisal Ahmed

Reviewer #2: Yes: KIRAN SOOD

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A quality management system aiming to ensure regulatory-grade data quality in a glaucoma registry

PONE-D-23-02739R1

Dear Dr. Urushihara,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Simon Grima, PhD

Academic Editor

PLOS ONE

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