Do you have a monitoring report to write? Find are our 8 essential points for a top monitoring report.

The texts below are strictly for example. Each CRA has his/her own way of writing. The idea is to find important information and to answer the following questions when you write out a report: who, what, when, how? We recommend you to ask your clinical project manager for an annotated monitoring report to better understand his/her expectations, if this is not done yet. In addition, regularly refer to monitoring plan that will give you many elements to improve the quality of your report.

The monitoring reports are written in the 3rd person of singular (e.g. The CRA has reviewed the FIU n°4, 5, 6).

1. Included patients and consents

In this part, you specify how many patients are included in the center and where they are in their progress in the study (in follow-up, in process…). You must be accurate on the date of signing the consent and by whom.
For example:

Patient 01:

Signature of the general consent v1.0 of 17August 2014 by the patient and Dr. Dupont on 17 July 2015.

Signature of the pharmacokinetics consent v1.0 of 17 August 2014 by the patient and Dr. Dupont on 17 July 2015.

The patient is currently undergoing treatment, on the visit V1 (17 July 2015).

2. CRF and source file

Here you must specify the items you checked and if you have reviewed all the queries.

For example:

Patient 01:

Monitoring of visits V1 (full verification), V2 (full verification), V3 (partial verification), EI (partial verification) Concurrent treatments (partial verification)

To date, the queries have all been reviewed, revised and monitored.

3. SAEs

First, it is important to confirm whether there were or not SAEs in the center. You should also specify whether they were declared in time or not.

A monitoring of SAEs and FU (Follow-up) of SAEs should be done in your report, you must also specify whether you monitored data related to this SAE or this FU of SAE. You can write sentences such as:

« Patient 001: SAE « hospitalization for back pain » was declared by Prof. XXX on date of XXX » The SAE has not been declared within 24 hours to the pharmacovigilance services. On XXX, the CRA has monitored all data about the SAE. A follow-up of SAE must be reported as soon as new information is received by the investigator. The investigator, co-investigators and the CSC were retrained to the management and declaration of SAEs. This major deviation was reported to the clinical project manager on the day of the visit »

4. Deviations

All deviations found during your visit should be reported in your monitoring report. You should also make distinctions between minor, major deviations and violations to the GCP or protocol. You also have to specify the reasons for these deviations and what the investigator has implemented to prevent this from recurring (preventive actions) and what they have implemented to correct the deviation (corrective actions).
For example:

Minor deviation: The ECG was not performed during the visit V1. The CSC forgot to perform this test because it was not reported on the working document normally that he uses usually in the context of the study. The working document used by the CSC was amended by the CSC so that this type of error cannot happen again. In addition, the CRA has rechecked the working documents to ensure that all study tests are well reported. The investigator and the CSC were retrained on various tests required as part of the study. A reminder sheet was sent to the team so they can refer to it.

In general, deviations are classified as follows:

Minor deviations: requirements, practices or processes that are not likely to affect the rights, safety or welfare of subjects or integrity of quality and data.

Major deviations: requirements, practices or processes that may affect the rights, safety or welfare of the subjects or the quality and integrity of data.

Violations (of critical order): requirements, practices or processes that affect the rights, safety or welfare of subjects or the quality and integrity of data.

In practice, clinical project managers sometimes develop listings clarifying the type of deviations that they regard as minor, major or critical. Think to ask him if you have a doubt.

5. The issues that is to say, problems or malfunctions

Throughout your report, you must describe the problems and ways to solve them. In general, you should report at the end of the report, the summary of all the issues that took place during the visit, as well as issues unresolved during the previous visit.

I recommend you to give a number to each issue and keep this number over time, this will allow you to better track your issues and to realize quickly if you did something wrong (e.g. deletion of an unresolved issue) or if the issue is very old.

Issues must normally be resolved from a visit to another. It is not always easy according to the different activities to be treated or to the goodwill of the investigation team. However, be proactive and try to resolve all issues before your next monitoring visit. Your report will be even lighter.

For example:

1. The content of the investigator workbook

You have to do a summary of the missing documents from your checklist of investigator workbook.

« For example: The investigative workbook is stored in a locked cabinet. It has been updated by the CRA that day.

The following documents have been stored in the workbook:

–
–
–
The following documents are currently missing and will be forwarded before the next monitoring visit. »

–
–
–
All missing documents will of course be reported in the list of issues so that you do not forget to manage this issue.

1. Treatments

You have to report if you went to the pharmacy, you report in your report, the number of treatment received, used since the last visit. You specify whether the account is accurate. You can also talk about patient compliance and calculate it. You can talk about destroyed treatments, obsolete treatments. You must specify also whether the treatments were maintained properly and checked temperature readings.

For example:

The CRA has visited the pharmacy on 17 May 2016. The CRA has reviewed the ambient temperature readings from 14 February 2016 12 a.m. to 17 May 2016 12 p.m. No temperature excursion was observed.

Accounting of treatments:

5 vials (Expiry date: 7 July 2018) have been received since the last visit.

4 vials were used (destroyed on 17 May 2016, a certificate of destruction has been provided).

Only 1 vial (Expiry date: 7 July 2018) to date.

An urgent order was made by the pharmacist. The CRA has retrained the pharmacist on the need for regular orders of treatment.

1. The material of the study

You can specify the number of laboratory kits that remain in the center.

For example:

It remains:

• 0 kit: Screening
• kit: V1 (Expiry Date 22 May 2019)
• 1 kit: V2 (Expiry Date 22 May 2019)

An order of kits was made by the CRA on the day of the visit.

Writing a full report is crucial for monitoring an investigation center, you have to write it so that any other CRA can resume your work and understand what it is. You have to be specific about who, what, when, how?
For reminder, in case of inspection or audit, your reports will be scrutinized, so you have to remain rigorous and prudent.