10 essential tools for a monitoring of quality!
I present to you Helen. Helen is currently working with me at Pharmaspecific. We decided to write an article in common on the subject of monitoring. We give you here all our tools for a monitoring of quality.
Are you doing regularly monitoring? Do you have you all the necessary tools for quality monitoring? Let’s compare our monitoring bags!
1. Calculation Calendar
2. Your Dorosz and your medical dictionary
Not without my Dorosz. The Dorosz (drugs guide) is the essential tool in monitoring, especially when you need more information about a drug. I already wrote an article about it; do not hesitate to visit here.
3. A pocket version Protocol
A protocol version A4, that’s good. But a mini-protocol, it is even better! 🙂
Do you have the protocol in PDF format? To create a pocket version, you just have to print the document in 4 times smaller, cut the sheets with a cutter and link pages with a spiral. It is up to you now.
4. CRF filling guide and reference tools (ladders in print…)
In my monitoring bag, I always have the CRF filling guide, which is usually provided by your project manager and that allows to know all the instructions needed to fill the eCRF.
Also, I always have with me ladders and other reference tools. This allows me to check more quickly the source document. For example, in oncology, I always have the NCI-CTCAE (listing and grading of adverse events).
5. The list of tasks to perform on-site
The list of tasks to perform on-site helps me to remember everything (and save time!) before finishing my monitoring. This document lists all the activities to be performed on site. For example: “Check the eligibility criteria,” “Check that the delegation form of the center’s tasks was signed by XXX” or “Resolving query X for the patient X.”
Once the task is completed, I put a cross next and I can move on to the next activity. If the action has not been made by the center, so I put ND (for “Not Done”) or NA (for “Not Applicable”) and I add a comment if needed.
I usually create such document to each of my monitoring visits by adapting it each time. I also added the date, visit number and address of the center.
This tool will also help you to write your monitoring report, so to save time!
Before concluding my monitoring visit, I check that all issues were addressed and treated.
Typically, the post-it are ideal for highlighting in the source documents without a signature, a header or a field to be completed, etc.
But beware, you must check in company procedures where you work or with your project manager if you can use post-it: they are not recommended sometimes because they could be misinterpreted in case of an emerging audit.
In addition, they can be removed by the investigator or by the clinical research technician in your absence and it is a disaster!!!
I use them sparingly. It is best to use in addition a “monitoring editing notes.”
7. Monitoring editing Notes
A problem during the review of CRF? To centralize the problems, I use monitoring editing notes.
When there is an error in the case report form, I write the section of the CRF concerned and the problem to solve. With that, I can control the evolution of the problem at each visit and thus achieve better monitoring of difficulties encountered on site.
8. Patient worksheet (patient monitoring sheet)
During my monitoring visits, I take with me blank forms specific to each patient.
This form helps me during the visit at the time of writing my report, but also in my future visits.
Its purpose is not to rewrite all the information that is already in the eCRF but noted the important information specific to the patient, which will allow me to monitor the CRF. I write in short in this form a part for some concomitant medications and for AEs and SAEs.
9. Specific calculators to study
Before starting the monitoring visits, I prepare Excel spreadsheets to track visits of my patients. I can follow and forecast dates of the visits of patients in the study and calculate the differences allowed by the protocol
10. The checklist of investigator workbook (ISF checklist) and your list of SUSARs
Do not forget to take with you the checklist ISF (Investigator site file = investigator workbook) and your list of SUSARs (Suspected unexpected serious adverse reactions). Indeed, the investigator workbook must be updated with the new documents of the study.
The checklist and SUSARs list are often given by the project manager of your study, contain all documents required to be kept in the workbook. At each visit, you must update this checklist to ensure proper monitoring of the center’s documents.
The workbook must contain all statements of SUSARs for the study. Your SUSARs list will allow you to assure you that all statements are present in the workbook, visit after visit. I put it regularly clean and updated.
A good monitoring is synonymous with quality tools … well-chosen and well prepared! And you, do you use other monitoring tools? Come share your tips with our community for monitoring.
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