Guidelines for Data Submission
Suggested Biostatistics Lead Times
Biostatistics recommends the following lead times for requesting statistical support:
- Grant proposals
- P01: 12 weeks
- R01: 4 to 6 weeks
- R21, R03, and other grants: 4 weeks
- Letter of Intent for future grant submission: 2 weeks
- Clinical trial protocols: minimum 8 weeks. Protocol development for a Sylvester sponsored clinical trial is highly variable and usually spans a period of 2 to 6 months. A recent review of 56 protocols developed in collaboration with Biostatistics statisticians indicated a median of 58 hours of Biostatistics effort, and a range of 31 to 88 hours.
- Letter of Intent for clinical protocol: 3 weeks
- IRB protocol for a clinical study other than a clinical trial: minimum 6 weeks (highly variable)
- Statistical analysis (assuming a complete, numerically coded electronic database has been prepared)
- for initial submission of meeting abstracts: 3 weeks
- for final preparation of meeting abstract/poster/presentation: 4 weeks
- for manuscripts reporting final study results: 4 weeks and often several months
- Database consultation: 4 weeks
Allow additional time and resources for data preparation, in consultation with Biostatistics, if necessary.
Biostatistics can provide consultation regarding database structure as part of study planning in collaboration with the BBC Systems Development group. However, investigators must make their own arrangements for data collection and entry.