17 Multi-Site Study

If this is a multi-site study (i.e., a study in which two or more institutions coordinate, with each institution completing all research activities outlined in a specific protocol) and the Penn State PI is the lead investigator, describe the processes to ensure communication among sites in the sections below.

17.1 Other sites

List the name and location of all other participating sites. Provide the name, qualifications and contact information for the principal investigator at each site and indicate which IRB will be reviewing the study at each site.

[Type protocol text here or indicate as not applicable]

Not applicable.

17.2 Communication Plans

Describe the plan for regular communication between the overall study director and the other sites to ensure that all sites have the most current version of the protocol, consent document, etc. Describe the process to ensure all modifications have been communicated to sites. Describe the process to ensure that all required approvals have been obtained at each site (including approval by the site’s IRB of record). Describe the process for communication of problems with the research, interim results, and closure of the study.

[Type protocol text here or indicate as not applicable]

Not applicable.

17.3 Data Submission and Security Plan

Describe the process and schedule for data submission and provide the data security plan for data collected from other sites. Describe the process to ensure all engaged participating sites will safeguard data as required by local information security policies.

[Type protocol text here or indicate as not applicable]

Not applicable.

17.4 Subject Enrollment

Describe the procedures for coordination of subject enrollment and randomization for the overall project.

[Type protocol text here or indicate as not applicable]

Not applicable.

17.5 Reporting of Adverse Events and New Information

Describe how adverse events and other information will be reported from the clinical sites to the overall study director. Provide the timeframe for this reporting.

[Type protocol text here or indicate as not applicable]

Not applicable.

17.6 Audit and Monitoring Plans

Describe the process to ensure all local site investigators conduct the study appropriately. Describe any on-site auditing and monitoring plans for the study.

[Type protocol text here or indicate as not applicable]

Not applicable.