A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan.

BACKGROUND: The DIA Clinical Data Management Community created a committee to develop a model standard operating procedure (SOP) for writing a data management plan. METHODS: The goal of the committee was to develop a plan that could be used by industry and academic institutions. The model was based on contributed examples from committee members and their experiences with current practices and technologies. It is understood that as new clinical trial technology is implemented, the SOP will require modification. RESULTS: The model SOP and associated templates are presented as a starting point, and each company or institution will need to modify them to meet its individual needs. CONCLUSION: The model DMP SOP produced addresses most data management issues that are present in any phase clinical trial while providing a flexible framework.

A 21 CFR Part 11 compliant graphically based electronic system for clinical research documentation.

Clinical research protocols are intricate and detailed. Regulatory authorities including the U.S. Food and Drug Administration require full documentation of all procedures, including who performed them and when they were performed. Paper based study records are becoming ever more voluminous as the requirements for detailing every item continue to grow. Although the current approach is to transfer required data to electronic databases, each protocol requires uniquely designed databases. Therefore, at present, it has not been possible to design generalized electronic databases which serve for each individual study which can serve as primary source documentation. We have taken a new approach, by developing an electronic graphically based source documentation technology which in every way mimics and maintains the advantages of paper recordkeeping. We use tablet computers as paper surrogates, feeding data archives maintained on central servers. Our system uses widely available non-proprietary components and programs. We meet the requirements enunciated by the US Food and Drug Administration for electronic systems. These include requirements to maintain data integrity, backup of data, validation of all system components, safeguards on digital signatures, and a date and time stamped audit trail. This system has been used by our group successfully for more than 2 years encompassing over 20 pharmaceutical research studies.

Neck posture and head movement in four rescue stretchers.

Neck posture and head movements were measured in four rescue stretchers: the Neil Robertson stretcher, which has been in service in the Royal Navy for almost 100 years, and three potential replacements. A repeated measures laboratory study was carried out to quantify neck posture and head movements while subjects reclined in the stretchers. Stretchers were compared on the basis of this critical aspect of their performance to complement the findings of ship-based usability trials. When the subjects were secured in each of the stretchers, wearing cervical collars and any restraints integral to that stretcher, the resting posture of the neck and the range of voluntary movement in flexion/extension, lateral flexion, and rotation were measured. In all of the stretchers, the neck was in an extended posture. The collars restricted head movements but they did not immobilize the neck. Stretcher 3, which had all of the functionality of the Neal Robertson stretcher, but with integral backboard and head blocks, limited head movements the most.