Sample Collection After IEC Approval

1. Obtain and File IEC Approval Documents

• Collect the written, dated approval letter from the IEC/IRB.
• Ensure the approval covers the specific protocol version, informed consent form (ICF), and any patient-facing materials.
• File all IEC correspondence in the Trial Master File (TMF).

2. Site Initiation & Team Readiness

• Conduct a Site Initiation Visit (SIV) — train all team members on the approved protocol.
• Confirm that the Delegation of Authority Log is signed, clearly listing who is authorized to collect samples.
• Ensure all staff handling samples are trained in Good Laboratory Practice (GLP) and, if applicable, hazardous material handling (IATA DGR certification for shipping).

3. Informed Consent Process

• Identify eligible participants using the approved inclusion/exclusion criteria.
• Obtain written informed consent — the participant must sign and date the ICF before any study procedure begins.
• In emergency situations where consent cannot be obtained beforehand, consent must be obtained from the participant or their legally acceptable representative as soon as possible (per ICH E6 R3 / GCP guidelines).
• Retain the original signed ICF in the study files; give a copy to the participant.

4. Pre-Collection Preparation

• Confirm the participant's identity and eligibility at each visit.
• Prepare required equipment as per the study-specific specimen collection manual (provided by the sponsor or lab vendor).
• Label all collection tubes/containers with the subject ID, visit number, date/time — never with participant names (to maintain blinding/privacy).

5. Sample Collection

• Collect samples strictly per the approved protocol (correct time points, sample type, volume).
• Document the collection in source documents at the time of collection — date, time, collector's initials, any deviations.
• Any protocol deviation (e.g., incorrect volume, wrong time point) must be documented and reported per the site SOP.

6. Specimen Processing & Storage

• Process samples within the timeframe specified in the protocol (e.g., centrifuge within 30 minutes, aliquot, freeze at −80°C).
• Log samples into the specimen tracking log (sample ID, storage location, processing time).
• Maintain cold-chain integrity throughout.

7. Shipment to Laboratory

• Package and ship samples per the sponsor's shipping manual and IATA Dangerous Goods Regulations (if applicable).
• Include a chain-of-custody manifest with each shipment.
• Record dispatch in source documents.

8. Ongoing IEC Compliance

• Report serious adverse events (SAEs) and any unexpected findings to the IEC promptly.
• Submit protocol amendments for IEC review before implementing any changes that affect sample collection.
• Provide continuing review reports to the IEC at the frequency specified in the approval (typically annually).

Key Regulatory References

Sample Collection & Data Recording Procedure

Interhemispheric Connection — Behavioural Assessment in 8-Year-Old Children

General Pre-Session Requirements

TASK 1: Bimanual Tapping Task

Purpose

Materials Required

• Two touch-sensitive digital tapping pads OR two marked squares (10×10 cm) on paper with a pen/stylus in each hand
• Stopwatch or digital timer
• Audio metronome (app or device) — set to 2 Hz (120 BPM)
• Data recording sheet (see below)

Procedure

• Instruct the child: "Tap with one finger on each pad as fast/rhythmically as you can, one hand at a time."
• Allow 3 practice trials (10 seconds each) for dominant and non-dominant hands separately.

• Dominant hand tapping alone: 3 trials × 15 seconds each, 30-second rest between trials.
• Non-dominant hand tapping alone: 3 trials × 15 seconds each, 30-second rest.
• Record: number of taps per trial for each hand.

• Child taps both pads simultaneously with index fingers of both hands.
• Condition A — In-phase (synchronous): Both hands tap together at the same time.
• Condition B — Anti-phase (alternating): Hands alternate (L-R-L-R).
• 3 trials × 15 seconds for each condition, 30-second rest between trials.
• Record: number of taps per hand per trial, errors (missed beats, phase slips).

Data to Record

Key measure: A higher intermanual interference index indicates weaker interhemispheric inhibition/coordination.

TASK 2: Bimanual Coordination Task (Circles–Lines Coupling)

Purpose

Materials Required

• Tablet PC (preferred) or two sheets of paper on opposite sides of a midline marker
• Pen/stylus for each hand
• Protractor/software to measure ovalization index (if using tablet)
• Stopwatch

Procedure

• Child draws continuous vertical lines (up-down) on paper with dominant hand — 30 seconds.
• Child draws continuous circles with non-dominant hand — 30 seconds.
• Record separately for each hand.

• Child simultaneously:
  • Draws vertical lines with dominant hand (right side of table)
  • Draws circles with non-dominant hand (left side of table)
• Duration: 3 trials × 30 seconds, 30-second rest between trials.
• Starting posture: both hands begin at midline before each trial.

• Swap: circles with dominant, lines with non-dominant.

Data to Record

Ovalization index increases when the circle-drawing hand is "pulled" toward the lines movement — the larger the OI, the weaker the interhemispheric independence.

TASK 3: Tactile Intermanual Transfer Task (TIMT)

Purpose

Materials Required

• Opaque bag or box (child cannot see inside)
• 10 everyday 3D objects of varying shape/texture (e.g., coin, eraser, key, button, marble, cube block, cylinder, triangle block, ring, spoon)
• Blindfold (to ensure no visual input)
• Data recording sheet

Procedure

• Child is blindfolded.
• Tester places one object in the child's right hand for 10 seconds of free exploration.
• Object is removed. Child is asked to identify it from an array of 5 objects placed in front (visual array, blindfold removed).
• Repeat with left hand placing + left hand identifying.
• 10 trials per hand. Record correct/incorrect.

• Child is blindfolded.
• Tester places object in the right hand for 10 seconds of exploration.
• Object is removed. Child must identify it by feeling with the LEFT hand (from 5 objects in an opaque bag — no vision).
• Repeat in reverse (left hand explores → right hand identifies).
• 10 trials per direction. Record correct/incorrect.

Data to Record

A large transfer deficit (ipsilateral much better than intermanual) indicates reduced callosal somatosensory transfer.

Data Recording Sheet (Master Template)

Participant ID: ___________   Date: ___________   Tester: ___________
Age: 8 yrs ___ months         Sex: M / F           Handedness (EHI): R / L / Mixed

TASK 1 — Bimanual Tapping
  Dominant unimanual:     T1___ T2___ T3___   Mean: ___
  Non-dominant unimanual: T1___ T2___ T3___   Mean: ___
  Bimanual in-phase (D):  T1___ T2___ T3___   Mean: ___
  Bimanual in-phase (ND): T1___ T2___ T3___   Mean: ___
  Bimanual anti-phase (D):T1___ T2___ T3___   Mean: ___
  Phase errors:           T1___ T2___ T3___

TASK 2 — Bimanual Coordination
  Unimanual lines: velocity/distortion ___
  Unimanual circles: OI% ___
  Bimanual circles OI%: T1___ T2___ T3___   Mean: ___
  Observer notes: ___________________________

TASK 3 — Tactile Intermanual Transfer
  Ipsilateral R-hand: ___/10     L-hand: ___/10
  Intermanual R→L: ___/10        L→R: ___/10
  Transfer deficit index: ___

Order of Task Administration

• Group A: Task 1 → Task 2 → Task 3
• Group B: Task 3 → Task 1 → Task 2
• Group C: Task 2 → Task 3 → Task 1

Important Notes for 8-Year-Old Children

• Keep each session under 45 minutes total (attention span)
• Provide short breaks (2–3 min) between tasks
• Use child-friendly language: "Let's play a hand game"
• If a child is distressed, stop and note in the record — do not include that trial
• Do not give feedback on performance (to avoid learning effects between trials)
• All sessions should be conducted at the same time of day for each child (morning preferred — avoid post-lunch drowsiness)

• Van Mier & Hulstijn (2006) — Bimanual interference in children, Frontiers in Human Neuroscience
• Frontiers in Human Neuroscience (2025) — Circles–Lines Coupling Task in children 5–13 years
• ICH E6(R3) GCP Guidelines — Specimen/data collection procedures