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					Source Document Completion Guidelines

The following information will assist you in the creation of source documents to be used at DCRU or
MCRU. Please contact Jennifer Maas, Quality Assurance Coordinator, with any questions:

Office # 626-9142
Email engen081@umn.edu


    1)      Header
            a. Include the location of the visit (MCRU or DCRU).
            b. Include CTSI Protocol # and a short protocol title.
            c. List the name of the person who created the source documents under “Originated by”.
               Also include a contact number (office, cell, etc).
            d. List the date the source document was originally created. Also include revised dates
               when revisions are made.
            e. Include the following subject information:
                    i. Subject initials
                   ii. Subject number

    2)      Study Staff Contact Information
            a. Include contact information (phone #, pager #, cell #) for the PI, Study Coordinator
               and any other MDs that may be working on the protocol or backing up the PI (e.g. Sub
               Investigators, Medical Safety Contact, etc).

    3)      Visit Name
            a. Create source documents for each individual study visit. Complete visit information at
               top of page. Include date of visit in the following format: DD/MMM/YYYY.

    4)      Allergies
            a. Please list any medication allergies or other pertinent allergy information (paper tape
               allergy, latex allergy, food allergies, etc). If none, include “No known allergies”.

    5)      Admission Instructions
            a. List any pertinent information that the MCRU/DCRU staff should know or do upon
               admission to the unit. If no instructions, add “Not Applicable”.

    6)      Special Medication Instructions
            a. List any medications/infusions that MCRU/DCRU staff should order and from which
               pharmacy (IDS, Fairview, etc.). Include a completed and signed Physicians Order.
            b. List who will pick up medications from Fairview Pharmacy and/or IDS Pharmacy.
            c. Provide preparation instructions (if applicable) that MCRU/DCRU staff will need to
               perform.
            d. Provide any pertinent information you feel the MCRU/DCRU staff should know.
            e. If no instructions, add “Not Applicable”.




Source Document Completion Guidelines (v.3 06Dec2011)                       Page 1 of 3
    7)      Protocol Directed Time Point Column
            a. Please indicate when procedure should be performed per protocol (pre-dose, 0-hour for
               dosing, and post dose). If pre-dose procedures need to be performed within a certain
               time of the dose, please indicate in this column (15 minutes pre dose, 5 minutes pre
               dose, etc).


    8)      Actual Time and Staff Initials Column
            a. MCRU/DCRU staff will document the actual time the procedure was performed, if
               required. If time is not required, shade out column or enter NA (Not Applicable).
               MCRU/DCRU staff will also initial the procedure they completed.


    9)      Instructions/Procedures Column
            a. Include all procedures that the MCRU/DCRU staff will need to perform.
            b. Include fasting information, any resting restrictions for ECG’s, vital signs, etc.
            c. If weight needs to be obtained, please indicate whether pounds or kilograms should be
               documented.
            d. If height needs to be obtained, please indicate whether inches or centimeters should be
               documented.
            e. For temperature, indicate whether Fahrenheit or Celsius should be documented.
            f. Include any special instructions while obtaining vital signs (take pulse for 30 seconds,
               use manual blood pressure cuff, etc).
            g. When listing blood tubes, spell out the types of tubes that will be used (red top tube,
               purple top tube, gold top tube, etc). Please no abbreviations. For any tiger top tubes,
               please spell out the colors (red/black, green/gray, etc…).
            h. List all blood tubes to be drawn in the following order unless protocol specifies
               otherwise:
                     i. Yellow top tube
                    ii. Light blue top tube
                   iii. Red, red/black tiger, or gold top tube
                  iv. Green, light green or green/gray tiger top tube
                    v. Lavender or purple top tube
                  vi. Pink, white, or royal blue top tube
                  vii. Gray top tube
                 viii. Dark blue top tube
            i. If a urine pregnancy test will be performed at MCRU/DCRU, please include the following
               information on the source document:
                     i. Lot number of pregnancy test
                    ii. Expiration date of pregnancy test
                   iii. Control: Valid or Invalid
                  iv. Result: Negative or Positive

    10)     Comments Column
            a. For MCRU/DCRU staff to document important information the Study Coordinator and
               Investigator will need to be made aware of regarding subject visit.


Source Document Completion Guidelines (v.3 06Dec2011)                     Page 2 of 3
    11)     Discharge Instructions
            a. Include any information that MCRU/DCRU staff should be aware of prior to discharging
               subject from unit.
            b. If no instructions, add “Not Applicable”.


    12)     Adverse Event Page
            a. MCRU/DCRU staff will document any adverse events that subject may experience
               during the visit.
            b. MCRU/DCRU staff will not complete the shaded areas.

        Note – This page can be used for adverse events that occur with the subject when the
        coordinator is not present. If not needed, delete page from source document.


    13)     Send completed source document to Quality Assurance Coordinator for review
            prior to first subject visit.
            a. If you have difficulties with formatting the form, send the form as is and the QA
               Coordinator will do this during the review.
            b. Once reviewed, QA Coordinator will send back to Study Coordinator. Form can now be
               used for subject visits.

    14)     Revising source documents
            a. It is up to the Study Coordinator to make revisions to the source document(s) for any
               IRB approved protocol amendments. In the event a revision is required, make
               revision(s) and email to QA Coordinator for review. QA will follow same process as
               listed above.
            b. REMINDER – Study Coordinators will also need to update lab-processing instructions
                in the event of a protocol amendment.

            NOTE – Please contact Jennifer Maas, QA Coordinator with any questions.




Source Document Completion Guidelines (v.3 06Dec2011)                    Page 3 of 3

				
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