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
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.
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
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
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
d. If height needs to be obtained, please indicate whether inches or centimeters should be
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
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.
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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
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