In this part, we'll be discussing wrapping up your study as part of the when you're done set of videos. In particular we're going to cover study close-out procedures. What that means and what they are. The diversity of policies for record retention and data archival and an overview of data destruction. So what exactly is study closure? When do you close a study? Your study is ready to close when you are no longer following up study subjects. You have completed all interactions with them and you have finished all your data work. You're basically indicating that no further work will be done on this project. As in a side, closing patient recruitment or enrollment is not the same as study closure. And if you're working on a clinical trial, you will probably need the approval of your study monitor before you can shut down the study. Strategic study closeout has several aims. It ensures that you document all study activities, that they are complete. Show that your obligations as an investigator have been met. Also, the obligations of your sponsor and your monitor. And demonstrate that you understand your post-study responsibility. It's also a process in which you inform your Institutional Review Board that your study is changing status. You could wrap up your study as planned, or you could have to do an unscheduled study close-out. That can happpen when the study is shut down because of safety or validity concerns. Maybe the drug is too toxic or someone detected scientific fraud. Or your interim results are over, overwhelmingly positive or negative, in which case it would be unethical to continue providing the inferior intervention. Or your interim results are inconclusive. In a big expensive trial, you'd conduct a utility assessment. To see if the trial is worth continuing, or maybe competing research is published, funding dries up, or key study personnel leave and can't be replacced. Or even disasters. Perhaps your study relies on reviewing hospital records and the hospital records room burns down. It would be hard to continue that project. So these events can lead to an unscheduled close-out. Scheduled or unscheduled, though, study close-out is a complicated process, and you need to know what to do in advance. The time to plan your close-out procedures, is during the start-up phase of your study. With planning, you can implement a close-out strategy that ensures ethical treatment of study participants, secure handling of data, and the budget to cover your final work as well as long-term record retention. Study close-out has many steps, but we're focusing specifically on those related to data management. You should keep a checklist of the data procedures you need to complete during close out activities. Ensure all your forms, for every patient, are collected, complete, and legible. Make sure all the collected data are entered into the electronic database. Run quality checks on your data. Send out queries about any errors and then resolve all those open queries, and finally, lock the database once everything is final. You'll also need to implement your study's record retention and record destruction procedures. So, what should you keep as part of record retention? Study documents are closely tracked and can't just be trashed during study close out. You should keep your essential study documents, both electronic and paper. Section 8 of the GCP guideline lists over 50 types of documents you should keep. Also keep frozen versions of all data sets and analysis scripts used to inform reports and publications. Any hardware or software required to read your electronic files and backups of those files. And, how long should you keep those records. Well, the issue has gotten pretty muddled. And there are many sources of policies. Some of the sources include the good clinical practice guideline, or GCP. The US office for human research protections. The U.S. Food and Drug Administration, EudraLex, which is the book on rules governing medicinal products in the European Union, or the IRB supervising your study might have its own regulations, your trial sponsor, and even your institution. The good clinical practice guideline, for example says at least two years you should keep your records but check with your sponsor. The OHRP asks that records be retained for at least 3 years after completion of the research. The European Commission on the other hand states the sponsor and the investigator shall retain the essential documents relating to a clinical trail for at least five years after its completion or for a longer period for if so required. Essential documents shall be archived in a way that ensures that they are readily available upon request. To the competent authorities. The medical files of trial subjects shall be retained in accordance with national legislation and in accordance with the maximum period of time permitted by the hospital, institution, or private practice. To add to the list, my institution requires seven years. An older version of GCP, stated you should keep your records for 15 year. And some nations and institutions have set much longer time frames. Now, think back to a file that you created 15 years ago. Do you even know where it is? Have you been backing it up in secure locations all these years? You might have stored it on a floppy disk. Do you still have a floppy drive on your computer? Or if it's on a CD. Are you sure that CD hasn't degraded, so the file is no longer readable? And what type of antiquated file format is that file stored in? Do you have a copy of the software that generated it? Does that 15 year old program still run on your operating system? And we didn't even touch on paper records, or film records, which have to be stored at a particular temperature, safeguarded from fires and floods. With access to them, secured and tracked for all those years. Plus you're expected to deliver any of these files promptly, if they're requested. These are all challenges of data retention. It's more expensive and time consuming than you think. In contrast, data destruction seems pretty easy. You have someone with proper study authorities sign off on the files destruction. Then, document what is being destroyed, when, and by whom. There's no escaping record retention policies in the end though. You have to keep track of the log of record destructions. If possible, use a confidential paper recycling service to handle your document destruction. Many research institutions engage a service like this. These companies often handle x-rays and other films too, plus they provide certificates of destruction for your items. It's not always possible to outsource your record destruction though, US regulations provides some guidelines on proper disposal methods. For sensitive paper documents consider shredding, burning, pulping or pulverizing the records, so that protected health information is rendered essentially unreadable Indecipherable and otherwise cannot be reconstructed. For sensitive electronic media, your good options include clearing it, which is using software or hardware products to overwrite media with nonsensitive data. Purging it, de-Gaussing or exposing the media to a strong magnetic field in order to disrupt the recorded magnetic domains or destroying the media. Disintegration, pulverization, melting, incinerating, or shredding. I hope you've gained a general picture of study closeout procedures. In summary, prepare for study closeout early. Resolve open queries and lock your databases. Keep your essential study documents in a safe place. Check your sponsor, institution, and national guidelines for how long you should keep them. And if you have to destroy confidential documents, do so securely.
