Standard of care procedures can be excluded from the study protocol. If there are research related procedures being conducted that can be replaced with standard of care procedures within a specific time period they can be included in the list of procedures and denoted as standard of care. For example: A physical exam must be conducted for screening purposed but if one was conducted within the past 30 days for standard of care purposes, this can be used for screening/eligibility. If standard of care procedures are being conducted in a specific manner with procedures conducted solely for research purposes they may need to be included in the study procedures section but denoted as standard of care. This can be very helpful when determining the budget for the study. Include windows around study visits if applicable to the study so as to reduce the number of visits, which are considered to be out of the visit window timeframe. For Example: Randomization Physical Exam Vital Signs Laboratory Tests Quality of life assessments Dispensing investigational product (for devices could involve implantation at this time) Visit 2 List of all the procedures that will take place at study visit 2 For example: Physical Exam Laboratory Tests Medical Records Review Assess possible adverse events Review medication changes and updates Be certain to include details on any sort of genetic testing that may be taking place Dispensing and return of investigational product Visit 3 Etc. Phase 2 of the Study (if applicable provide details, for example open label phase) General description of the study procedures to take place. Follow Up Phase of the Study Visit X List all procedures that will be performed at all follow-up visits. These can be described in summary, unless the procedures vary depending on follow-up visit. If procedures vary, include a visit-by-visit description as in the section above. If the follow-up visits are conducted by telephone or mail, describe the procedures that will be followed. End of Study Visit Describe the study visit including a list of all procedures to be conducted at this visit. Include details about any sort of subject debriefing which will take place at this visit or any type of results which will be shared with the subject at this point in time including if they will be unblinded.
Standard of care procedures can be excluded from the study protocol. If there are research related procedures being conducted that can be replaced with standard of care procedures within a specific time period they can be included in the list of procedures and denoted as standard of care. For example: A physical exam must be conducted for screening purposed but if one was conducted within the past 30 days for standard of care purposes, this can be used for screening/eligibility. If standard of care procedures are being conducted in a specific manner with procedures conducted solely for research purposes they may need to be included in the study procedures section but denoted as standard of care. This can be very helpful when determining the budget for the study. Include windows around study visits if applicable to the study so as to reduce the number of visits, which are considered to be out of the visit window timeframe. For Example: Randomization Physical Exam Vital Signs Laboratory Tests Quality of life assessments Dispensing investigational product (for devices could involve implantation at this time) Visit 2 List of all the procedures that will take place at study visit 2 For example: Physical Exam Laboratory Tests Medical Records Review Assess possible adverse events Review medication changes and updates Be certain to include details on any sort of genetic testing that may be taking place Dispensing and return of investigational product Visit 3 Etc. Phase 2 of the Study (if applicable provide details, for example open label phase) General description of the study procedures to take place. Follow Up Phase of the Study Visit X List all procedures that will be performed at all follow-up visits. These can be described in summary, unless the procedures vary depending on follow-up visit. If procedures vary, include a visit-by-visit description as in the section above. If the follow-up visits are conducted by telephone or mail, describe the procedures that will be followed. End of Study Visit Describe the study visit including a list of all procedures to be conducted at this visit. Include details about any sort of subject debriefing which will take place at this visit or any type of results which will be shared with the subject at this point in time including if they will be unblinded.