Informed Consent

To be supplied

Drug and Pregnancy Tests

• For all interview sessions, our participants must pass a drug test for inclusion into the study. We use Amedi-Check urine drug tests, and they are in the file cabinet in the cubicles. For REW22 and Trauma interview sessions, we also do a urine pregnancy test
• For all MRI sessions, the participants must pass a urine drug screen and a pregnancy test. Pregnancy tests are stored with the drug screens.
• For PET scans, participants must pass a urine drug test, and the serum pregnancy test (female participants must show up ~1.5 hours prior to the PET scan to give ample time for the analysis of the serum pregnancy test)
• If a subject tests positive on either test, ask them about the result, and if they deny possibility of the positive result, it is okay to re-do the test if they are willing.
• Each of our studies have a urine drug test at every session

Urine Protocol

• When having a participant do a urine drug screen, you will want to use an exam room with a biohazard bin. Ideally the room will have a two way door that connects to the bathroom. The 1.5T and 4T exam rooms have this.
• Give the test and the paper bag to the subject. Ask them to screw the top on tightly when they are finished and to either a) place the test in the shelf of the two-way door or b) place it on a paper towel on the shelf near the mirror
• Be sure to wear gloves
• Peel back the label on the drug test to analyze. If you are doing a pregnancy test at the same time, use the urine from the test to drop into the pregnancy test.
• When you have confirmed the test is negative, you must pour the urine into the toilet and screw the cap back on.
• Then with one hand gloved (to hold the test) and the other ungloved (to open/ close doors) bring the tests back to the exam room and dispose of them in the biohazard bin.

Physiology: Blood Tests, ECGs, and Biopsies

Taking Blood Samples

To be supplied

Quest

• As noted earlier, we use Quest Diagnostics for our bloodwork
• During the study session, be sure to bring the Quest form and the quest baggie to the session.
• Once you have obtained your blood samples:
• Be sure to label each tube with the subject ID, DOB, and sex. Fill this out on the form as well.
• On the form indicate the tests you want run, check the box “bill to my account”, write “Dr. Olson” as the study doctor, and check “Fax results to: 617-855-4231”
• Call Quest for specimen pick-up
  • 617-547-8900 (provide study-specific or general screening account #) to schedule pick-up
    • write down confirmation number on your copy of the requisition
  • If you have expired tubes to dispose of, let them know that they will be picking them up as well and place them by the specimen pick-up box.
• The Quest specimen pick-up box is located on the ground to the right of the wooden desk in the foyer of the entrance of the MIC (clearly marked, keyed access).
  • Keys to the Quest specimen pick-up box are by the front door of the RA office 127b
  • Bob Baden will be able to order you a key to open this box.

ECG (“EKG”) Training

• You will need to be trained on administering ECGs
• In order to do an ECG on a female you must be female or have a doctor present
• Rooms that you can do the ECG in are the 1.5 and the 3T exam rooms (for the 3T, you must bring the ECG)
• The ECG will print out an analysis of the recording. It is often hyper sensitive, and therefore it will often report an abnormal ECG when it is in fact fine. You must bring all ECGs to the study doctor to approve.
• If an ECG prints out as abnormal, replace the electrodes, and try again. If it is still abnormal, try to find the study doctor to review while the subject is still at the NIC. Otherwise, save the ECG for review later. Don’t tell the subject that they have an abnormal ECG. Only the doctor can determine this. Say “I am only trained to administer the ECG, and not to read it. We need to have the study doctor review the ECG for study eligibility”
• Remember to write the subject ID on the ECG printout

Biopsies

To be supplied

Administering REDCap Suveys /Data Entry

Some information may be out of date

• Method 1: Open a public survey
  • Log in with your partners ID
  • Go to “My Projects” and select the survey
  • Click “Manage Survey Participants” on the left hand side
  • Click “Open public survey”
• Method 2: Open a survey for this participant
  • Log in with your partners ID
  • Go to “My Projects” and select the survey
  • Click “Add/Edit Record”
  • Enter a new or existing Participant ID (e.g., REW23-001)
  • Fill out the first section of the survey for the participant, this includes the Study ID (e.g., REW23, ELS), the Subject ID (e.g., 001);, the Session Number (e.g., 2); and the Date (select Today).
• Option 3: Send a link to the survey
  • click “Participant List” under the manage survey participants tab.
  • This will send an email to participants with a link so that they can fill it out at home
• When you are ready to download the data to analyze, go to “Data export Tool” and click “export data now”. You will most likely want to export the “raw” excel spreadsheet
• If you need to change existing data (e.g., entered the wrong subject ID, administered the wrong questionnaire), you can export the data, make your changes, and then use the “data import tool” to upload your edited data.
• You will have to design an excel template that analyzes the questionnaire data exported by RedCap. Design the template so that you can copy the subject data and, without having to edit the data, paste it into the template.
• Scoring templates and data dictionaries for individual questionnaires can be found in common/admin/measures/scoring templates.
• It is also important to share access to questionnaires so everyone can use them. To do this, first select the project to share, under applications select “User Rights”, enter the Partners ID of the person who you are giving access as ‘New user name’ and hit tab, you then select their permissions: select everything in the first third, hit Save Changes. The person you added should then receive an email to let them know.