Clinical trials are the way that most new treatments are tested for initial efficacy and are becoming much more public in the wake of the COVID-19 pandemic.
If you are sick, having easy access to your medical records is important for a multitude of reasons. But if an appealing or selective trial opens up, having your records available and organized prior to joining a clinical trial could save you time and stress and help you secure a spot in the trial. Even if you are not sick, in order to join a trial, you will likely be required to produce an extensive set of your medical records.
Just to be eligible for most clinical trials, having your past six months (at least) records available is the ante to participating. But your records are important for more than just your entry pass. Careful scrutiny will be given to ensure underlying health conditions won't cause you to face unknown health risks by your participation.
Clinical trials are required to obtain and maintain detailed medical records of all participants. Sometimes it seems sufficient for patients to provide a verbal history of his or her medical details. And some trials have in fact done this. But most clinical trials know that this is not sufficient.
From the organization’s perspective, without your clinical records, your participation may disqualify your results from the trials reported findings, or worse, may disqualify the trial in its entirety. It is highly likely that the FDA will review records of participants to ensure the appropriate qualifications and safeguards are met. And should your specific results vary from the norm, your medical records can help the study understand whether there were other factors that caused that anomaly.
Gathering Records in Advance
Below are 6 steps to obtaining your medical records in advance of your clinical trial. It is important to consider starting this process before the need arises to ensure you are prepared when the opportunity to participate in the clinical trial arises.
- Make a checklist of all prior procedures including location (provider/hospital) and date.
- Contact the providers. They may have an online portal for you to collect your records. If they do, note the login credentials and instructions on your checklist.
- Download your images from the portal if you have a place to maintain these records like your own computer or some secure cloud-based storage. Remember that not all public storage is sufficiently secure.
- If your provider does not have an online portal, make an analog request in writing or by telephone.
- Follow up with providers if you do not hear back. Most requests must be fulfilled within thirty days of the receipt of your request.
- Be sure you keep this set of records current. As you undergo additional procedures, add to your checklist and continue your vigilance.
What Are Your Rights to Your Records
You have the absolute right to obtain your own medical records. But in most cases, you have to ask. Some providers will charge you to gain copies of these records. Those charges are governed by federal and state regulations, which generally force these fees to be “reasonable,” although reasonableness varies based upon the type of record (images, documents, etc) and the volume of what will be generated (number of pages, discs, studies, etc).
Normally, the response to your request must occur within thirty days. Now you can see why you should be thinking about this in advance. Sometimes thirty days is just too long in order to guarantee your eligibility to participate in a particularly selective trial.
Types of records
You likely have various types of medical records, each with some unique characteristics. Medical images from your scans may take the form of large electronic files that you will have to obtain either via a link to your providers’ storage or on portable electronic media like a CD or thumb drive. Pathology images are often digitized as well, and may be too large to even fit on a disc.
Paper records that include medical opinions, test results, or data from physician’s visits are also important to capture. Sometimes these are available electronically as well. However, more often these come as photocopies or faxes.
Be sure you don’t neglect noting the dates of your diagnosis or treatment, as well as any pharmaceutical prescriptions or over-the-counter drugs. It is important to retain dates of surgery, chemotherapy, or any other tests that you may have had along the way.
Organizing, storing & sharing
Having your records available or knowing where they are is important. Ensuring that you have an effective way to deliver them to where they are needed is your next challenge.
If you have physical copies of your records, you can always mail or courier them to the appropriate location. However, that may be slower than you need and can be expensive. For records that you still need to obtain, you may need another way.
There are several services out there that may help if you have your records in electronic format. Purview has a free online uploader (Purview Capture) that enables both you and your providers to electronically and quickly upload your records to any location free of charge. Any size or type image, test result, or even scanned document are accepted. Once uploaded, records can be shared with one simple request.
Let your provider know about this web site. They may find this is the most cost-effective way to ensure that both you and your clinical trial site obtain your records in a timely manner.