5 STUDY SPECIFIC PROCEDURES or MANUAL OF PROCEDURES This section (or alternate location if other file system is used) must contain the study specific procedures (SOP) or manual, if applicable. Each study specific procedure or Manual of Procedures (MOP) must have a Version number and date. All Versions used throughout the study must be maintained in the file. The Study Specific Procedures or Manual of Procedures may include the Laboratory Procedures Manual, Laboratory Specimen Handling instructions, test article handling and/or preparation, and Protocol-specific instructions. Note: Deviations from the Study Specific Procedures or Manual of Procedures must be documented in a similar fashion as Deviations of the Protocol. 6 SUBJECT SCREENING/ENROLLMENT LOG List all subjects considered for this (e.g., all subjects from your IRB/IEC approved institution that you screened for this study). A study number or screening number must be used on this list and an ID Code list that links those numbers must be kept. For study purposes, records cannot
5 STUDY SPECIFIC PROCEDURES or MANUAL OF PROCEDURES This section (or alternate location if other file system is used) must contain the study specific procedures (SOP) or manual, if applicable. Each study specific procedure or Manual of Procedures (MOP) must have a Version number and date. All Versions used throughout the study must be maintained in the file. The Study Specific Procedures or Manual of Procedures may include the Laboratory Procedures Manual, Laboratory Specimen Handling instructions, test article handling and/or preparation, and Protocol-specific instructions. Note: Deviations from the Study Specific Procedures or Manual of Procedures must be documented in a similar fashion as Deviations of the Protocol. 6 SUBJECT SCREENING/ENROLLMENT LOG List all subjects considered for this (e.g., all subjects from your IRB/IEC approved institution that you screened for this study). A study number or screening number must be used on this list and an ID Code list that links those numbers must be kept. For study purposes, records cannot
Regulatory%20Document%20Guidelines.docx