Source Documents For Clinical Trials Template

Clinical trial source documents are the roadmap and clinical record to let me.

Source documents for clinical trials template. Access request link please use these directions to add support roles to a study. Budget monitoring tool. Source document used in the study. This form is also used to modify access permissions. Communications about a specific subject should be filed with source documents for that subject.

Ocr research forms and templates. Clinical translational research portal portal time tracking change request please use this form to add modify remove a time tracking role from a study. Study visit source documentation template. Includes communications to and from the sponsor and or the study team. As a cra i regularly visit the sites to review the study conduct encourage study participant recruitment evaluate the ongoing suitability of the investigative site provide protocol specific training track investigative supplies and to review source documents.

The nccih clinical research toolbox provides a web based information repository for investigators and staff involved in nccih funded clinical research. Document any agreement or significant discussions regarding trial or administration protocol violations trial conduct adverse event reporting etc. Maintain adequate and accurate source documents and study records that include all pertinent observations on each participant. Well designed source docs are the data foundation of a successful clinical trial. Source document templates include inclusion exclusion worksheet adverse event tracking log medications log missed visit early withdrawal form study visit form randomization form study procedures form physical evaluation form.

These templates are for pis and their study coordinators and should be used as examples or templates to build from and modify to meet their specific needs. Office of clinical research forms and templates. Portal project update request. Its background rationale objectives design methodology statistical analysis plan and organization with the protocol you can make sure you protect the participants and collect the data. Prepare template form s to assist source data collection for the study.

The toolbox contains templates sample forms and information materials to assist clinical investigators in the development and conduct of high quality clinical research studies. Author paula smailes rn msn ccrc ccrp is a clinical research specialist at the ohio state university department of family medicine. Clinical study report template. Archival of essential documents sop. Refer to appendix 3 for the template source document identification log.

Support roles are accountant pi co pi scheduler etc. Archiving trial data sop. Creating source docs is also an excellent way to thoroughly learn a study and clarify any ambiguities. Essential documents checklist investigator site file master file set up and maintenance sop. Trial master file contents list.

All clinical research starts with the research protocol a document that details all aspects of the trial.