Best practices for maintaining and storing essential documents in clinical research

The complexity of a clinical research trial involves keeping and storing multiple essential documents that are necessary for a successful trial and quality results. The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity.

1. Best Practices for Maintaining and Storing Essential Documents in Clinical Research

2. Introduction The complexity of a clinical research trial involves keeping and storing multiple essential documents that are necessary for a successful trial and quality results. The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Nowadays, with the increased need of using the online world for multiple functions at a clinical research site, many people wonder if it’s even necessary to store these essential documents in their physical copies. So, do you actually need physical copies of documents? Or is it enough to store them in an online database? The answers to these questions and much more can be found below. ‹#›

3. Which documents are essential in a clinical trial? www.trialjoin.com ‹#› Current protocol; Previous protocols; Protocol amendments; IRB approvals; Monitoring (Site Visits) Log; IRB correspondence;

4. Which documents are essential in a clinical trial? www.trialjoin.com ‹#› Subject Visit Log; Screening and enrollment log; List of subject identification codes; HIPPA forms; Protocol deviations; IP-related documents;

5. Which documents are essential in a clinical trial? www.trialjoin.com ‹#› Advertising and marketing materials; IND safety reports; CFRs; Informed consent forms;

6. www.trialjoin.com Do you need physical copies of the essential documents? Even though all businesses are slowly transferring their work online, when it comes to clinical research, some (or better all) of the essential documents will still need to be kept in their physical copies. ‹#› Keeping a physical copy of documents in clinical research is especially important when it comes to the current protocol, all previous protocols, and protocol amendments together with their IRB approvals. Even if the new protocol has already been approved, you will still need to keep physical copies of all former protocols. Although your site might use electronic record systems to store all the trial data, it’s best if you also keep physical copies of these important documents. The FDA and the sponsors are still used to reviewing physical copies of regulatory documents, so not having these copies will definitely stir up trouble!

7. N o free platforms Protected with an IRM 21 CFR part 11 compliant HIPPA compliant www.trialjoin.com What kind of online database can be used for storing trial documents? Online Database ‹#›

8. www.trialjoin.com What kind of online database can be used for storing trial documents? ‹#› provide the option to give and forbid access respect the confidentiality and privacy of patients be able to see whoever tries to enter the database allow you to have a better control over all the data The electronic database system or program that you use for your site data should be secure enough in order to...

9. www.trialjoin.com What kind of online database can be used for storing trial documents? ‹#› Online free storage platforms such as GoogleDrive or OneDrive are not a good option for clinical trial data storage! There are many cases when sites had to pay huge fines because their systems didn’t contain such features! Remember that even if you are using a good online database, the FDA and the sponsor will still want to see physical copies of your most essential documents!

10. www.trialjoin.com What to do if keeping physical copies is a problem? In cases when keeping physical copies of essential documents becomes a problem, ask the sponsor or the study manager if they would have a problem with your site storing data online, in a secure database. Most of the time, they will not agree to this! However, you can try explaining to them that you will use a secure database, thus continuing to work in compliance and protecting privacy and confidentiality. If they agree to this, there are a few steps that you need to follow in order to properly transfer your documents online. ‹#› Ask the sponsor/study manager! Explain them that your database is secure! Two outcomes - allow or deny!

11. Electronic Storage of Essential Documents www.trialjoin.com ‹#› All documents have to be indexed which will allow an easier retrieval; All electronic copies of documents have to be certified ; Each page of the electronic document has to be reviewed to confirm that all pages are present and accurate; A certification statement has to be filled out; All possible security measures have to be used to protect the documents from unauthorized leakage and/or access; Guidelines 1 2 3 4 5

12. Electronic Storage of Essential Documents www.trialjoin.com ‹#› IRB approval is necessary for converting paper documents to electronic; Ensure the storage database possesses all the necessary encryption and backup features; Sponsor’s permission of storing documents in an online database has to be obtained; The PI is responsible for maintaining all data records and ensuring that the implementation of electronic data storage is proper; 6 7 8 9 According to the FDA: ‘’A certified copy is a copy of original information that has been verified , as indicated by a dated signature , as an exact copy, having all of the same attributes and information as the original.’’

13. www.trialjoin.com How to keep documents at a Satellite Site? ‹#› A satellite site or a remote site is a secondary site where clinical trial subjects are seen, normally under the control of the same PI (principal investigator) that is responsible for the primary site. There are many different reasons why a satellite site is used, such as: for being closer to potential subjects for recruitment; the requirement for specific resources and facilities that the primary site doesn’t possess but are needed for the study protocol. No matter what might be the case, the PI needs to be able to conduct and/or supervise all sites that are working on the same study.

14. PI Supervision Physical Copies vs Online Database The Quality of the Online Platform www.trialjoin.com FDA Areas of Concern Even though the FDA doesn’t have a specific definition of satellite sites, it’s possible that they’ll express concern in these 3 areas: The FDA’s main concern is the ability of the PI to provide proper supervision, especially when this remote site is located in a geographically distant area. In such cases, the FDA advises that the PI delegates some of his/her duties to sub-Is (sub-investigators) who will always be present at each remote study site. These sub-Is will then be obliged to follow the PI’s orders and give regular reports and updates. Many site owners or PIs wonder if the sponsors require keeping physical copies of documents at remote sites, or is it enough to keep these documents only at the main site.Usually, most sponsors will ask you to keep physical copies of some of the most important and essential documents: the current and all previous versions of the protocol, the Investigator Brochure, IRB approvals, correspondence, and procedural manuals. The final and most important thing to remember when it comes to storing documents in an online database is to carefully choose the service provider. You will need a quality platform that supports compliance in order to not have any regulatory problems. Furthermore, make sure to restrict access to unauthorized people, and allow access to the appropriate staff members. ‹#›

15. www. trialjoin.com CONCLUSION Even though following the above procedure is necessary when switching from paper to electronic forms of documents, we still encourage you to keep physical copies of the most important documents in a clinical trial: current and previous protocol, protocol amendments, and IRB approvals. Keeping them in your Regulatory Binder, properly filed and easily accessed will help you a lot during an FDA or a sponsor audit. Finally, one last thing to remember, is to always maintain all your documents and records in an accurate and timely manner, in order to allow the study to run smoothly and the final data to be produced with high quality and integrity! ‹#›