Protcol Entry Form Instructions
Protocol Information (Field names in order of tabs)1. Date: The system should automatically enter the date on which the form is being completed (this is the default). If a different date is desired, delete and enter the desired date.
2. PI: Enter name of Principal Investigator. This is the investigator responsible for the study, as it will be listed in the IRB approval.
3. Contact: Enter name of the assistant or contact person for this study. This person and phone number will be given to volunteers, and used by the Coordinator for scheduling and questions. If the PI is also the Contact person, please re-enter this information. Please do not leave this section blank.
4. Phone: Phone number for Principal Investigator.
5. C Phone: Phone number for Contact Person.
6. IRB #: Format for this field is ##i/c## (# meaning any number 0-9)This is the identification number for this study in the database. All studies entered into the database must be IRB-approved. Enter your IRB number here.
7. Email: E-mail address for Principal Investigator.
8. C Email: E-mail address for Contact Person.
9. Protocol Type: Indicate whether this is a treatment or non-treatment study. The database will not match volunteers to more than one treatment study at a time.
10. Protocol Title: Enter title for this study as it appears on your IRB approval form.
11. Notes: Indicate any pertinent information for this study not captured elsewhere on the form.
12. Number of Participants Needed: Indicate the number of Outpatient and healthy control volunteers you need for this study. Increase this number as needed to account for attrition.
13. Approximate duration of first visit: Indicate the amount of time volunteers can expect to be here for their first study visit. If this is different for patients and controls, indicate in the notes field.
14. Duration of subsequent visits: Indicate the amount of time volunteers can expect to be here for subsequent study visits. If this is different for patients and controls, indicate in the notes field.
15. Number of study visits: Indicate total number of study visits volunteers will need to complete for this study.
16. Payment: Enter the total payment possible for this study, per participant.
17. Payment Details: Indicate payment specifications. For example, if participants will be paid as they complete multiple portions of a study, please indicate (i.e., MRI scan: $20; Interviews: $20; Cognitive testing: $20, Bonus for completing all parts: $10. Total payment:$70.)
18. Description: In lay terminology, please provide a short, concise paragraph to tell volunteers what they will do to complete this study. This description will be provided to patient and healthy volunteers, and used to advertise and recruit for your study, so please be clear in your terminology. Include any general tests they will complete (i.e., memory tests, EEG, MRI scans), and any other measurements that may influence their participation (blood draws, drug administration, etc.). See sample entry form for example.
Volunteer Information
Demographic Inclusion Criteria: Indicate the demographic criteria required for your patients and healthy controls. Any characteristics that you check here to include in your study will be matched to your protocol. Those people in the database not matching these requirements will not be referred to your study.
Gender: Check gender of volunteers to include in this study.
Age: Enter minimum and maximum age criteria for this study.
Ethnicity: Check volunteer ethnicities inclusion criteria for this study.
Race: Check volunteer races to include in this study.
Handedness Inclusion: Check volunteer handedness to include in this study. Volunteer handedness will be based on self-report only.
Subject Education Code Inclusion: Indicate levels of participant education to include in this study.
Native Language: Indicate inclusion requirements for participant’s native language.
Only subjects who have a working knowledge of English language will be referred to your study from the pool.
If original/native language does not matter, check all boxes to include.
Diagnosis Inclusion Criteria
Diagnosis Inclusion Criteria: Indicate all DSM-IV diagnostic groups you wish to include in your study. Clicking on the information icon will provide you with a list of DSM codes. To seek specific diagnoses, indicate DSM code with as many decimal places as needed for your protocol (e.g., to include only Schizophrenia, Paranoid type, enter number 295.30). To seek more general diagnoses, use the % key to replace decimals (e.g., for all types of schizophrenia, enter 295%). List current diagnoses to include and lifetime history of diagnoses to include in their respective columns.
If you have any questions about DSM-IV diagnoses, please contact the project PI, Dr. William Greenberg, at 845-398-5496.
Medical Information- Exclusion Criteria
Indicate all conditions you want excluded from your protocol.
1. Subject has contraindications to MRI. Check to exclude subjects who are not MRI compatible. Subjects may not be MRI compatible if they have permanent metal implants in or on their body (such as a pacemaker, bone or joint pins, IUD, etc.), weigh over the MRI weight limit (approximately 300 pounds), or are known to be claustrophobic.
2. Subject is currently pregnant. Check to exclude volunteers who are currently pregnant. Concerns may arise for MRI studies, or for those involving drug administration.
3. Subject is hearing impaired. Check to exclude subjects who are hearing impaired. This may have implications for auditory processing studies. Subjects will only be listed as hearing impaired if impairment is significant (i.e., wears one or two hearing aids).
4. Subject is vision impaired. Check to exclude subjects with significant visual impairment. This may have implications for visual processing studies. Only subjects not corrected to normal vision with glasses or contacts will be indicated as visual impairment.
5. Subject has history of stroke. Check to exclude subjects who have personal history of stroke.
6. Subject has history of seizure or epilepsy. Check to exclude subjects who have personal history of seizure or epilepsy.
7. Subject has history of significant head injury (i.e., with loss of consciousness greater than 30 minutes). Check to exclude subjects who have history of severe head injury. May have implications for MRI studies.
8. Subject is known to be HIV positive. Check to exclude subjects who are known to be HIV positive. All other subjects will be assumed to be of “unknown” HIV status.
Diagnosis Exclusion Criteria (Controls and Outpatients)
Indicate all current and lifetime diagnoses that you wish to EXCLUDE in your controls and patients from this protocol.All diagnoses will be based on SCID interview in accordance with DSM-IV criteria, by trained research staff at NKI. Please note differences between criteria for drug “abuse” and “dependence”, and for current or lifetime diagnoses.
For questions regarding which diagnoses you may want to exclude in your controls or patients, please contact the PI, Dr. William Greenberg (845-398-5496) or Melissa Benedict (845-398-5486).
Please contact the Melissa Benedict Research Coordinator. at 845-398-5525 for further information or assistance.