The document outlines the check-in and compliance processes for subjects participating in a study, including steps for physical examination, informed consent, and identification verification. It emphasizes the importance of detailed procedures and forms, as well as critical processes for monitoring and blood collection. Additionally, it highlights the need for staff dedication and stringent adherence to protocols throughout the study phases.

1. Click to
go to Study Check-in Process
page 1
Physical Examination Compliance, Bag Informed Consent
Subject ID Verification
(As applicable) Search & Vital Signs (Period 1 only)
Photo ID check
(1a)
Subject screening Compliance Subjects are read
File checked with Questionnaire the ICF by the
the Wrist Band (3a) RN / Designate
(2a) (4a)
Subject Signs the
Check in Record
(1b) Vital Signs Check
Physician (3b) Ensure that they
completes physical have understood
examination forms while they consent
(2b) for study
(4b)
Restricted items
confiscated,
Signature Laptop camera
Verification with taped
Records (3c)
(1c)
PI renders subject Subjects Sign the
eligible for the ICF document
study
(2c) (4c)
Detailed body &
Preprinted wrist Bag Search
band checked and (3d)
applied to the
hand of the
Subject.
(1d) PI Signs the ICF
document
Breathalyzer (4d)
(Alcohol)
(3e)
CRITICAL
PROCESS
(Amend SOP & Urine Sample
Form) collection
Nicotine + Drugs Copy of ICF & Clinic
of abuse rules distributed to
(3f) subjects
CRITICAL
PROCESS (4e)
(Needs more
dedicated Staff)
CRITICAL Beta- HCG for all
PROCESS female subjects
SOP needs to be (3g1)
Click to go
followed and Strict to page 2
monitoring in place
CRITICAL
PROCESS
Other applicable
Restrictions to be
tests
observed more
(3g2)
stringent

2. Post Check-in Clinic Process
Overnight Pre-dose Pre-dosing day
Dosing day activities Post-dosing activities Check - Out
activities activities
* * * * *
Check-in Pre-dose Scheduled
Drug
Meal Vitals Check Blood Draws
Administration HSM, Vitals,
(5a) & HSM as per
(7a) ECG,
(6a) protocol
(8a) Biochemistry,
Hematology,
Sample Urine
Processing (9a)
Scheduled (8a1)
Hands Mouth
Vital checks,
Restrictions Check
Sleep ECG,
Start (Not for
(5b) Glucose &
(6b) Injectibles)
HSM. Blood Draw &
(7b)
(8b) catheter removal
(9b)
Subjects
Suitablity for Meals as per
Fluid Preparation follow posture
Dosing protocol
(5c) restrictions
(6c) (8c) Return
(7c)
Confiscated Items
to subjects
(9c)
Pre-dose
Beta-HCG blood
result report collection and End of Restrictions
collection catheter (7d) Wallet card,
(5d) insertion Snack &
(6d) Compensation
Results out of
Range PI should (9d)
be consulted
High Fat Breakfast before exit.
(if applicable)
(6e)
Subject Checks
Out
Release of SB’s (9e)
after PI
assessment
(If Applicable)
Subjects might
return for blood
draws as per study
requirement
*Continuous AE Monitoring & Record Click to go
to Page 3

3. Click to go
to page 2 Additional Process for Return Blood Draws
Return Blood Draws
Subjects
attend the
Clinic for
Return Blood
Draw
(10a)
Return Blood
Staff verifies
Draw Card
ID and Signs
given to the
subject in
subject
(10b)
(10b1)
Signatures
verified with
records
(10c)
Return Blood
Draw
Compliance
(10d)
Staff Checks
the ID and
the Return
Blood Draw
card
(10e)
Sample
Processing
(10f1)
Protocol required
activities e.g.
Vitals and Blood
Draw
(10f)
Subject
Compensation
(If Required)
(10g)
Subject Leaves the Clinic with
further instructions
(10h)
Click to go
to page 1