6.2 Description of Evaluations Descriptions for the Schedule of Evaluations define what is to be done at each study period and include special considerations or instructions for evaluations. This section should include definitions of the column headings in the Schedule of Evaluations and any special instructions. 6.2.1 Screening Evaluation These evaluations occur to determine if the candidate is eligible for the study. Consenting Procedure Before any screening procedure is performed, informed consent must be obtained. Indicate whether there will be two consenting processes or a single informed consent form that describes both the screening and study procedures. State which study staff will conduct the consent process and how it will be implemented. Describe and informed consent process; any plan for review of individual’s education consent document in case changes may be required; and how documentation of signed consent will be maintained by the study. Screening Specify allowable range of time prior to study entry during which all screening evaluations to determine eligibility must be completed. List and briefly describe all screening evaluations in bulleted format. Include only those evaluations that are necessary to assess whether an individual meets enrollment criteria. Discuss the sequence of events that should occur during screening and the decision points regarding eligibility. List the time frame prior to enrollment within which screening tests and evaluations must be done. For example, DXA must be measured within 30 days of study enrollment. 6.2.2 Enrollment, Baseline, and/or Randomization Enrollment The act of enrolling a study participant should be defined. Since informed consent must be obtained if screening procedures are not a part of routine care, some studies use two informed consents: one for screening and one for enrollment. In this case the enrollment date is day the individual has met all the screening criteria and signs the second informed consent form. Some studies utilize a single informed consent form that describes both screening and study procedures. In these studies enrollment is defined as the randomization date or as the date all of the screening criteria are met and the individual agrees to participate In any case the enrollment date should be defined and recorded on a case report form
6.2 Description of Evaluations Descriptions for the Schedule of Evaluations define what is to be done at each study period and include special considerations or instructions for evaluations. This section should include definitions of the column headings in the Schedule of Evaluations and any special instructions. 6.2.1 Screening Evaluation These evaluations occur to determine if the candidate is eligible for the study. Consenting Procedure Before any screening procedure is performed, informed consent must be obtained. Indicate whether there will be two consenting processes or a single informed consent form that describes both the screening and study procedures. State which study staff will conduct the consent process and how it will be implemented. Describe individual’s education and informed consent process; any plan for review of consent document in case changes may be required; and how documentation of signed consent will be maintained by the study. Screening Specify allowable range of time prior to study entry during which all screening evaluations to determine eligibility must be completed. List and briefly describe all screening evaluations in bulleted format. Include only those evaluations that are necessary to assess whether an individual meets enrollment criteria. Discuss the sequence of events that should occur during screening and the decision points regarding eligibility. List the time frame prior to enrollment within which screening tests and evaluations must be done. For example, DXA must be measured within 30 days of study enrollment. 6.2.2 Enrollment, Baseline, and/or Randomization Enrollment The act of enrolling a study participant should be defined. Since informed consent must be obtained if screening procedures are not a part of routine care, some studies use two informed consents: one for screening and one for enrollment. In this case the enrollment date is day the individual has met all the screening criteria and signs the second informed consent form. Some studies utilize a single informed consent form that describes both screening and study procedures. In these studies enrollment is defined as the randomization date or as the date all of the screening criteria are met and the individual agrees to participate In any case the enrollment date should be defined and recorded on a case report form