In honor of tax day in the United States, I thought I would outline the four ways that trial master file (TMF) management is like doing your taxes.
- Both are required
- Both require vast amounts of information and documentation
- Both have dedicated experts
- Technology can make both easier
TMF Management and Taxes are both required
The International Council has codified the expectations for how a Sponsor manages their clinical trial documentation. They have outlined which essential documents are required and how they should be handled. Each country/regulatory agency has likewise set expectations for TMF management as part of overall trial execution. If you do not comply with the expectations about adequately managing your TMF, you may have issues getting approval for your
The expectation that individuals file and pay taxes is likewise laid out by a country’s regulatory landscape. If you don’t file and pay your taxes, you could be fined and/or imprisoned.
Regulatory agencies have team members (inspectors and auditors) dedicated to evaluating your compliance with both TMF and tax expectations. These expectations and repercussions of non-compliance cause organizations and individuals to “do the right thing.”
TMF Management and Taxes both require lots of information
As anyone involved in TMF management can attest, there are over 200 classifications of documents that have been identified as standard components of the TMF. Each classification may have dozens (or hundreds) of individual documents filed in support of a clinical trial. It is often a demanding task to ensure that you have all the documents you need to pass an inspection.
For many people, the process of filing your taxes can be equally complex. You receive very detailed documentation from your employer and financial institutions. This documentation outlines revenue you received from your employer, interest and payments on investments, and other types of income you may receive. You must also collect information about childcare and healthcare expenses, donations you made to charitable organizations, and other expenditures. This copious amount of detailed information must be accurately entered into forms submitted to the IRS.
For both TMFs and Taxes, attention to detail and checking and rechecking are required to set yourself up for success.
Both TMF Management and Taxes have dedicated experts
As outlined above, TMF management and tax preparation are both complex activities that regulatory agencies mandate. These two factors drive many people/organizations to get help so they don’t have to do it themselves.
When it comes to TMF management, it is truly a shared burden. Sites generate a lot of documentation during the startup phase of the trial. Monitors (in-house or outsourced) tend to collect and manage the vast majority of the documentation on behalf of a trial. Sponsors tend to have a dedicated individual/team who serves as the TMF “owner” or champion. This TMF Owner is very familiar with TMF management and can guide the overall study team on TMF management best practices and expectations. They keep themselves up-to-date on evolving standards and regulations and usually have extensive experience with TMF management. Due to organizational constraints, some organizations outsource this TMF Owner to a third-party (either their CRO or a dedicated TMF support organization).
When it comes to taxes, we have all seen the plethora of ads, so we all know that dedicated tax professionals exist to help individuals with their taxes. Similar to how TMF experts know best practices, trends, and regulations, tax professionals are trained and proficient in tax preparation. Many individuals contract with these professionals to reduce the pain/effort involved in doing taxes and increase their comfort level.
Technology exists to ease the pain of TMF management and tax preparation
I just talked about how the burden of TMF management and tax preparation can be reduced by hiring an expert, but even when you are doing it yourself, it is easier to do now than it was in the past.
Regarding TMF management, we no longer have to create dozens of 3-ring binders to manage the TMF. TMF Software exists that makes it easier to identify which content you expect, load and file documents, and evaluate how inspection-ready your TMF is. Workflows and reports guide our activity, and we no longer have to document everything in manual checklists or Excel files. You still have to be vigilant and focused, but much of the manual effort has been reduced.
Regarding taxes, the days of using a pen and paper, calculator, and hard-copy tax form are in the past for many folks. Online tools like TurboTax make it easier to pull in the detailed financial information needed for your tax filing and guide you through the steps/questions to complete your taxes accurately. Again, you have to be focused and honest, but the tool makes it easier to complete taxes for those who want to do it themselves.