IntroductionThe John A. Burns School of Medicine (JABSOM), University of Hawaii, and The Office of Research and Development (ORD), The Queen’s Medical Center (QMC), see the need for coordinated and streamlined biostatistical/bioinformatical support for biomedical researchers (includes clinical, translational, basic). ORD has established a limited budget for QMC staff and affiliates to request biostatistical support through the JABSOM Office of Biostatistics & Quantitative Health Sciences (BQHS; http://biostat.jabsom.hawaii.edu). To manage the available funds, QMC staff in need of biostatistical support can access ORD funds under the following criteria:
- Investigator completes ORD Form 7 (download here) except sections marked in gray.
- Submits ORD Form 7 to the Pre-Award Coordinator (Lori Tsue, email@example.com). The coordinator will submit Form 7 to BQHS (Munirih Taafaki, firstname.lastname@example.org) with cc to investigator.
- The investigator initiates 1 hour consultation with BQHS by contacting Munirih Taafaki, (808-692-1812 or email@example.com), which will be supported by UH institutional infrastructural grants (NIH U54MD007584 RMATRIX and NIH U54MD007601 OLA HAWAII). This meeting allows BQHS to determine estimated costs. The researcher agrees that RMATRIX and OLA HAWAII will be acknowledged in any publication and presentation resulted from this biostatistical collaboration. Additional grant(s) may also need to be acknowledged.
- BQHS sends back ORD Form 7 to the Pre-Award Coordinator (Lori Tsue, firstname.lastname@example.org) with a rough outline of level of support and cost estimate, with cc to the investigator.
- The Director of ORD must approve the completed Form 7 for BQHS support. The Post-Award Coordinator (Lori Tsue, email@example.com) will post the approved Form 7 in the ORD database (RPTS).
- BQHS will invoice ORD through the Post-Award Coordinator. Together with the invoice, BQHS will provide the Post-Award Coordinator with a progress report. This will be used to determine whether the project is on budget. If not, the project has to be re-assessed for a change order or for an adjustment in the sampling analysis plan.
- Project costs may be capped depending on budget available.
Sample Size and Power CalculationsSample size and power calculations to ensure that the study will have adequate power to detect both the efficacy and safety outcomes of interest. The researcher needs to provide the minimum benefit that would be clinically relevant for the respective study population and research objective.
Note that in human research any changes to the SAP may also entail accountability to funding agencies, in particular the FDA. Any changes to the SAP have to be IRB re-reviewed to ensure that the rights, safety and welfare of the participants continue to be protected.
- Randomizing treatment groups - the randomization process is done by using a random number-producing algorithm (for randomized studies).
- Selecting a random subject sample - the same algorithm can be applied to chart review type studies for the purpose of identifying subjects.
- Perform the matching process in a matched case-control study.
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