Describe method of consenting for this patient

Using the schedule of events, create a source document from the template provided containing all of the screening elements (Eligibility Criteria through 12-Lead EKG).


  • You will not include AEs because they are logged separately, not by visit
  • Headers have been created for each element, but the formatting is entirely up to you.
  • DO research other templates, there’s a ton online
  • DO NOT copy and paste other templates into this template
  • DO think how best to collect this information, sequence, who needs to collect the data, do they need to sign and date the data collected?


The following assessments must be completed:

  • Obtain Informed Consent and Document the process
  • [Add all procedures here, in bullet format]

REMINDER:  Only trained personnel who are listed on the Delegation of Responsibilities Log are approved to perform these examinations.

Informed Consent

Was the informed consent obtained prior to any study related procedures?        No         Yes

Date patient or legally authorized representative signed informed consent:

_____ / _______ / ________               same as date listed on the header

DD        MON        YYYY

Was a copy of the signed and dated informed provided to the patient?       No     Yes

Was the patient given a chance to ask questions related to the study and were all questions answered to his/her satisfaction?  No      Yes


Please describe method of consenting for this patient: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________





Signature of person conducting Consent Process


INCLUSION CRITERIA: a patient must meet the following criteria at screening to be eligible for study:

1 Adult subjects 19 years of age or older, male or female Yes NO
2 Š   Female subjects must no longer have child-bearing potential (>1-year post menopause or surgically sterilized), or must

Š   have a negative urine pregnancy test, and

Š   be using and continue to use for 30 days after the study a medically effective method of contraception

Yes NO
3   Yes NO
4   Yes NO



A patient who meets any of the following criteria at either the screening visit or randomization will be excluded from the study:


1   No YES
2   No YES
3   No YES
4   No YES
5   No YES
6   No YES
7   No YES
8   No YES
9   No YES
10   No YES
11   No YES
12   No YES




____________________________________________________                    _______________

Principal Investigator’s Signature                                                                                              Date

Demographic Data

Vital Signs


12-Lead Electrocardiogram:

Clinical Laboratory Tests:

Medical and Surgical History:



Current Medication Intake:                      No       Yes

(If yes, fill in below)


          _ _/_ _ _/_ _
          _ _/_ _ _/_ _



Signature of person collecting medical/surgical history



_______________________________________________________                    _______________

Principal Investigator’s Signature                                                                                                     Date




  • I have created headers for each element, but the formatting is entirely up to you.
  • DO research other templates, there’s a ton online
  • DO think how best to collect this information, sequence, who needs to collect the data, do they need to sign and date the data collected?



Physical Examination (PE)


Head, Neck, and Thyroid                    Normal               Abnormal          Clinically Significant?


Ears, Nose and Throat                         Normal               Abnormal          Clinically Significant?


Chest                                                   Normal               Abnormal          Clinically Significant?


Lungs                                                   Normal               Abnormal          Clinically Significant?


Cardiovascular                                     Normal               Abnormal          Clinically Significant?


Lymph Nodes                                      Normal               Abnormal          Clinically Significant?


Abdomen                                             Normal               Abnormal          Clinically Significant?


Skin                                                     Normal               Abnormal          Clinically Significant?


Neurologic                                           Normal               Abnormal          Clinically Significant?


Musculoskeletal                                   Normal               Abnormal          Clinically Significant?


















Is Patient eligible?   Yes Date of Randomization and Treatment Visit? ­­­­­­­­­­­____________________________________

No  Reason(s) __________________________________________________________________





_______________________________________________________                    _______________

Principal Investigator’s Signature                                                                                                     Date


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