Remote clinical trials gained popularity at the onset of COVID-19. The virus brought about numerous restrictions such as lockdown, curfews and the abolition of any form of public gathering. It therefore became hard for monitors to visit their sites for review and transfer of data.

However, research work had to continue and most organisations decided to develop a strategy that would replace on-site monitoring. That gave birth to remote monitoring, which is less expensive and saves on time and resources.

You no longer have to pay a visit to a site for you to transfer and review any form of data. With the help of advanced technology, most organisations can monitor their data virtually through different mediums.

Standard Operating Procedures

In the past, most sponsors conducted their research and monitoring using on-site methods. But after the emergence of COVID-19, they had to formulate and develop standard operating procedures for remote clinical trials.

The pandemic increased acceleration of the use of virtual processes in clinical trials. Here are the guidelines for standard operating procedures.

1. Access Control

In remote clinical trials, it is best to know the individuals who will access all the trial files. When developing your SOP, you need to decide on a language that clearly states those who can access the trial files. It is important to include the following questions in your SOP: Who, what, when, how and where.

When talking of who, it points at either internal members who have specific roles in the trial or external members who include auditors, team members and any other third parties.

When it comes to how it indicates how members can gain access to the documents. Will, there be software that grants access or it will be through logins of a secure VPN.

When dictates the time and circumstances that you can access the documents. Are there specific days that you can access the documents? For instance, can one access them during working hours or only when visiting patients?

What talks of the kind of documents that members can access. The documents vary in terms of diseases, hospitals and locations.

Where denotes the location of the documents. You need to secure a location that will safely house the documents. Will you develop a comprehensive document management system or store them in a secure drive?

The above questions will help you manage the documents with effectiveness.

2. Effective Communication

You already researched on the most effective ways that your team members will use to communicate during the remote. The mode of communication needs to be standard for it to be up to date with information on data collection and clinical development.

This stage largely depends on aspects like new study status, updating new documents, cases of misplaced documents and any findings during the remote monitoring.

3. Conduct a Risk-based Remote Monitoring

It is important to use the FDA document to guide you on the best ways to use this approach. In times when you can no longer conduct on-site clinical trials, remote monitoring comes in handy. Therefore, your team members or organisations will need to incorporate the risk-based remote monitoring approach.

This method will yield good results at the end of the clinical trial. As a monitor, you can virtually view data and through aggregated study levels, statisticians can analyse all data trends in the clinical trials.

When using this approach, you will have to develop a system of how you shall be reviewing clinical data. You will also majorly focus on specific fields that you should remotely monitor.

After that, you can look for opportunities that will best suit your efforts in this approach. In the initial stages , you shall need no software to facilitate its operation.

4. Conduct Clinical Trial Data Review

To effectively start this off, your team needs to analyse areas that need reviewing in the remote monitoring clinical trial. As a sponsor, you shall need the combined efforts of the medical director, statistician and data manager.

Once you select areas that require reviewing, your team shall access the clinical data reports and review them remotely.

Developing an effective standard operating procedure will eliminate cases of misplaced information and duplicity.