Remember to address both data AND specimen handling in your protocol, when applicable
If your study involves keeping data and specimens for possible future research use, please remember to address the security and storage of both the data and the specimens in your protocol. We very often see what we think of as protocols with good intentions — their storage and use sections start out by mentioning both data and specimens, but after a sentence or two, they address only one or the other. And it’s extraordinarily rare that the same security and storage concerns apply to both — data, after all, is usually stored electronically, whereas specimens aren’t. It may be helpful to include address long-term storage in separate protocol sections, one for data and the other for specimens. The language should address where, exactly, the data or specimens will be stored; who will have access; whether they will include direct identifiers or codes, including where any key to the code will be kept; what the data and specimens might be used for; and how long they will be retained. Note that some of this information should be in the consent form as well.
If you’re involved in a study sponsored by a company or an outside entity, you may not have much flexibility to amend the protocol itself. If more information about data or specimen storage is needed to meet local requirements, you can always create a local addendum and upload it into CLARA along with your protocol.