November 14, 2023

9 Compliance Issues That Are Putting Sponsor Studies at Risk

Patient samples are the gateway to the insights that drive innovation in clinical research. Treating them with the care and attention that they deserve not only demonstrates an appreciation for the patients who are enabling the development of new treatments, but it also ensures that trial sponsors have timely access to all of the data that they need in order to make study decisions and submit to regulatory authorities.

Unfortunately, in the face of study complexity, lapses in site compliance have become far too common — simply because most sites are not being equipped with the tools they need to be successful. These breakdowns in the management of patient samples and sample data may not only increase patient burden, but they may also lead to critical data gaps that inhibit decision-making, delay regulatory submissions, and place added strain on study stakeholders. 

This blog dives into the most common compliance issues that are putting your study at risk — and what you can do to mitigate these problems.

1. Visit deviations

Patient visits cannot occur without the necessary lab kits and clinical inventory to collect, process, and ship patient samples. Unfortunately, many sites find themselves drowning in lab kits — making it difficult to keep track of on-hand inventory quantities, inventory locations, and expiration dates. As a result, patients may need to be turned away or rescheduled when a site doesn’t have the appropriate supplies on site for a particular visit. Some sites may attempt to build their own improvised kits using unexpired materials that they have on site, but this workaround is risky and may result in downstream issues with sample processing and data reconciliation.

2. Missed sample collection

Site staff are often juggling several patient visits at once. Caught up in the rush of a busy day, a phlebotomist or site nurse may forget to collect a required sample for a patient visit. This accidental oversight — oftentimes stemming from trying to quickly read through collection instructions or working from an older version of the protocol — may result in a visit deviation, incomplete data, or a repeated patient visit.

3. Sample collected or processed incorrectly

Even if all of the necessary samples are collected for a patient visit, site staff may make a mistake when collecting or processing a sample. Lab manuals often include detailed instructions for sample handling, but sometimes critical steps may be overlooked, resulting in downstream processing issues during sample analysis. If an important sample is deemed invalid, a patient may need to be brought in for a sample redraw — or even disqualified from the study entirely.

4. Sample lost at site or in transit

It’s not uncommon for studies to require sites to store samples for a certain period of time before shipping. Unfortunately, sites may be prone to losing these samples in their freezers, or otherwise forgetting about them as they balance all of their other responsibilities. Samples can also be lost in transit due to courier-related errors. Sponsors are typically unable to track the status of these samples, so they are not alerted to issues until it’s too late.

5. Sample shipped to wrong location

Site staff may occasionally ship a sample to the wrong destination lab by mistake. For instance, maybe a certain whole blood sample should be shipped directly to a specialty lab, but instead the study coordinator accidentally ships it to the central lab. This critical error can result in the sample being lost or otherwise not tested within the stability period. Because shipping documents are often siloed and paper-based, sponsors may not have direct access to tracking numbers and other pertinent shipping details, preventing proactive course-correction.

6. Sample shipped in incorrect condition

Every sample has very specific requirements for shipping temperatures; some may need to be shipped ambient, some may need to be shipped refrigerated, and some may need to be shipped frozen at various temperatures, like -20℃ or -70℃. Unfortunately, samples are usually invalidated when they are received at the testing lab in the incorrect condition — either because of a storage error, packaging error, or transit delay.

7. Sample shipped too late

Samples may need to be shipped out on the day of collection or shortly thereafter in order to ensure that the sample is still within stability upon arrival at the testing lab. Unfortunately, inadvertent oversights at the site and shipping delays can cause a sample to arrive at a lab too late — leading to sample cancellations.

8. Missing or incorrect data on requisition form

When samples are collected at the site, they often change hands across various staff members — from phlebotomists to study coordinators. Oftentimes, the person filling out the lab requisition form may not be the same person who collected the samples for that visit. If some of the data was not captured during the patient visit, then site staff may end up leaving certain sections of the requisition form blank. Site staff may also make a clerical error when filling out patient demographic information. Ultimately, these discrepancies will trigger a stream of queries.

9. Missing or incorrect data in EDC

In addition to filling out data on a lab requisition form, sites must also enter data into the EDC. When this data is incomplete or incorrect, sponsors and CROs must spend time working with sites to reconcile these discrepancies between the site data and the lab data. This process can be time-intensive and put significant strain on study stakeholders.

Leverage technology to mitigate compliance risks

Slope’s clinical trial execution platform enables sponsors to reduce gaps in sample data by empowering their sites to be more compliant with the latest version of the protocol or lab manual. Sponsors also have real-time access to the entire story of every sample so that they can streamline their reconciliation processes and quickly identify breakdowns along the sample journey. 

Read more about how Slope addresses widespread problems in end-to-end sample management. To request a free demo, click here.

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