Investigator Initiated Studies — 3 Common Problems and How to Fix Them

An investigator initiated study (IIS) is a clinical trial of a device that is sponsored by an independent researcher, rather than the manufacturer of the device. The clinical data generated by investigator initiated studies can be incredibly valuable to the manufacturers of the device, but unfortunately, not all of the data that comes out of IIS are suitable to be used for clinical evaluation.

Notified bodies have been very clear on this point: if you want to use data from IIS, you must be able to demonstrate that the study has generated high-quality data that was collected and managed in a compliant manner. That means compliance with Good Clinical Practice (GCP) and data privacy regulations like the EU’s General Data Protection Regulation (GDPR).

The main problem that device manufacturers run into with investigator initiated studies is that the investigators typically do not have the same level of experience as a Clinical Affairs professional. And that lack of experience often leads them to make mistakes with data collection that lead to potentially great clinical data being rendered unusable in the eyes of Notified Bodies. 

So, let’s walk through three of the most common problems with clinical data collection during investigator initiated studies. At the end of each section, I’m going to link to a free, customizable template that you can offer to investigators pursuing IIS with your device. These templates will help them avoid these problems without interfering in the study.

BONUS RESOURCE: Click here to download all 3 customizable templates that facilitate the use of clinical data from IIS in CER and PMCF reporting.

Problem #1: Consent of European data subjects in investigator initiated studies

In Clinical Affairs, “consent” typically refers to the informed consent that individuals must give before participating in the study. And while informed consent is an important part of collecting good clinical data, it’s not the only type of consent that investigators need to obtain.

Under EU GDPR, individuals must consent to the sharing of their data with third parties. That consent must be:

• Freely given
• Specific
• Informed
• Unambiguous
• Possible to revoke

If you’re a device manufacturer hoping to get clinical data from an investigator initiated study, data consent is paramount. If it’s done incorrectly, or not done at all, you will not be able to access that clinical data. There have been cases where studies went on for two or three years, with hundreds of participants, and the manufacturer ended up with no access to the data—simply because the patients never signed off on sharing their data with a third party. 

The issues here usually stem from the fact that independent researchers don’t always have legal counsel they can consult with before the study starts. They’re often relying on previous documentation, copying and pasting what someone else has done. That leads to issues like the mixing of informed consent and data consent into one form, for example. 

This is why it’s crucial to offer investigators support and guidance to ensure that data consent is being given in addition to informed consent.

Template #1 - EU GDPR Consent (privacy policy)

The free resource below is a consent template. It will help IIS researchers address what data they’re collecting, what data patients will share with investigators, and how it’s being processed and managed, as well as the subjects’ rights regarding their data. 

(Still, as we mention in the template, please seek legal advice before using it.)

BONUS RESOURCE: Click here to download the EU GDPR Consent template.

Problem #2: Adhering to Good Clinical Practice in data collection

Good Clinical Practice is one of the primary parameters you’ll be asked to demonstrate compliance with by a notified body. ISO 14155:2020 addresses GCP for the clinical investigation of medical devices for human subjects. 

Section 7.8.3 of the standard lays out a series of requirements applicable to any electronic records and electronic systems used for collecting and managing clinical data. There are three requirements in particular that can cause problems for researchers performing investigator initiated studies: 

d) ensure attributability, completeness, reliability, consistency, and logic of the data entered,
e) ensure accuracy of reports,
f) ensure that data changes are documented and that there is no deletion of entered data, i.e. maintain an audit trail, data trail and edit trail

These three requirements are important because if the data from an IIS is incomplete, inconsistent, or inaccurate, you can’t use it. Unfortunately, many manufacturers find that data from these studies have errors or other quality issues. 

Sometimes this is due to a lack of documentation regarding how data will be managed during the study or how statistical analysis will be managed. Investigators often rely on procedures that someone at their hospital or clinic wrote years ago and are now out of date.  

However, standards and platforms for electronic data capture  (EDC) also tend to vary from one study site to another—to the point where it’s not reasonable to expect two sites to have the same data collection tools and use the same workflows.

Template #2 - work instructions for electronic data capture

The following template is a document for facilitating the creation of a procedure or work instructions for electronic data capture (it’s also general-purpose and not specific to Greenlight Guru Clinical).

You never know what data capture tools investigators may be using in IIS, but the procedures and processes that need to be documented are always the same. If you provide them with a template that highlights those standard processes and procedures, then they can make it their own. This template:

• Provides documentation necessary to standardize clinical data management workflow.

• Provides a common standard for investigators participating in the study. How do they treat the data before, during, and after the study?

• Facilitates Good Clinical Practice, as one of the main requirements of GCP is that you document everything and keep records of what you do. 

BONUS RESOURCE: Click here to download the Work Instructions for Electronic Data Capture template.

Problem #3: Collecting the right data, correctly

Researchers and clinicians who are collecting and managing data don’t always have experience analyzing that data afterward. So when researchers control data collection workflows, they often use Excel spreadsheets and collect data without much thought as to how the structure or method of collection will affect data analysis later on. 

Unfortunately, that lack of forethought typically leads to poorly organized and mistake-filled Excel spreadsheets full of clinical data. And I want to be clear—this is a huge problem. Retroactive, manual “cleaning” of the data on the backend, in this day and age, is an antiquated notion. Yet it still happens all the time. 

Much of the problem stems from the way investigators structure their forms. Open-ended questions (free text responses), lack of data standardization, the potential for post-study data manipulation, and a lack of quality assurance checks can all lead to unusable data for manufacturers. 

When investigators use manual data collection methods (i.e. paper, Excel), anything short of the utmost administrative discipline can result in entry errors, improper documentation of data changes, and lost/unanswered data queries.

Template #3 - eForm designer

The template below is an eForm designer with predefined fields and checks and recommendations on structuring questions. The eForm designer encourages data structure and standardization to reduce data cleaning before analyzing, and it facilitates implementation of data validation to reduce errors.

Even if the researchers running the investigator initiated study are not using a purpose-built EDC solution like Greenlight Guru Clinical (which I strongly recommend), this template will reduce the risk of errors and help them collect high-quality data, correctly.

BONUS RESOURCE: Click here to download the eForm designer template.

Greenlight Guru Clinical is the leading toolbox for MedTech clinical data collection

You can’t control how an investigator initiated study is carried out, but you can offer support and guidance. I created these templates as a way for manufacturers to provide that support and help make sure that the study results in good, usable clinical data. 

However, you can control the way that your MedTech company carries out its own clinical trials. Planning and conducting an ISO 14155:2020-compliant clinical investigation is difficult enough without worrying about your data collection tools. 

That’s why we built Greenlight Guru Clinical specifically for the needs of the MedTech industry. It enables you to collect and manage clinical data in pre and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more.

Greenlight Guru Clinical also meets the regulatory requirements of the FDA, EU, and most other countries, and ensures compliance out-of-the-box with GCP and ISO 14155:2020. So if you’re ready to see what a purpose-built EDC solution can do for your organization, get your free demo of Greenlight Guru Clinical today→.